Medical Device Audits: Definition, Types, Requirements, and Process

An audit is a structured evaluation of processes to verify compliance with regulatory requirements or quality standards. Medical device audits assess whether a manufacturer’s QMS meets regulatory requirements, for example, under ISO 13485:2016, FDA 21 CFR Part 820, and EU MDR or IVDR.

Key medical device audit types include internal, supplier, and regulatory audits.

Medical device companies must audit core areas like design control, risk management, CAPA, production, and supplier oversight per applicable standards and regulations. A medical device audit process includes audit planning, clause-based evidence collection, classification of findings, and CAPA follow-up.

SimplerQMS provides fully validated QMS software with integrated audit management capabilities tailored for medical devices, and life science companies.

What Is a Medical Device Audit?

A medical device audit is a systematic, independent, and documented process to evaluate whether a medical device manufacturer’s Quality Management System (QMS) processes and product-related activities conform to applicable regulations, standards, and internal procedures.

The purpose of a medical device audit is to verify compliance, identify non-conformities, and assess the effectiveness of the QMS. A medical device audit ensures product safety, performance, and compliance with regulatory requirements.

Medical device companies are routinely audited by internal QA teams led by the Quality Manager, regulatory authorities, notified bodies, certification bodies, and customers.

Why Are Medical Device Audits Important?

Medical device audits are important for evaluating whether the Quality Management System (QMS) is effective and ensures product safety, performance, and regulatory compliance.

Medical device audits are also a regulatory requirement.  Manufacturers must conduct internal audits to ensure QMS compliance under FDA 21 CFR Part 820.22 (Quality Audit) which is aligned with ISO 13485:2016 Clause 8.2.4 (Internal Audit) EU MDR 2017/745 Annex IX details audit requirements for notified bodies when performing conformity assessments.

What Are the Different Formats of Medical Device Audits?

Medical device audits are conducted in two primary formats: on-site and remote. Both assess compliance with ISO 13485:2016, 21 CFR Part 820 (Quality System Regulation), EU MDR/IVDR, and other applicable regulatory requirements.

The choice of audit format depends on audit scope, regulatory expectations, risk level, and practical constraints such as travel restrictions, global operations, or distributed manufacturing sites.

Two primary audit formats are defined below.

• On-site Audits: On-site audits are performed at the manufacturer’s or supplier’s facility when direct observation of processes, records, or the site of production is needed. During on-site audits, auditors physically review documents, inspect cleanrooms or controlled areas, observe production activities, and interview personnel to ensure regulatory compliance.
• Remote Audits: Remote audits are conducted off-site using secure digital platforms that provide access to controlled QMS documents, enable virtual facility tours, and support video-based interviews. The remote audit format is used when on-site access is restricted or to conduct supplier audits across distributed sites.

What Are the Different Types of Medical Device Audits?

Medical device audits are classified into two primary types: internal audits and external audits based on the audit’s purpose and the party conducting the assessment. Each audit type ensures that quality system processes such as design control and risk management, are performed in accordance with documented procedures and regulatory requirements.

The different types of medical device audits are listed below.

• Internal Audits: Internal audits are systematic, independent evaluations conducted by the organization to assess the conformity, implementation, and effectiveness of their QMS against ISO 13485, internal procedures, and regulatory requirements.
• External Audits: External audits are independent, formal evaluations conducted by regulatory authorities, Notified Bodies, customers, or authorized representatives to verify a manufacturer’s QMS compliance with applicable regulations, standards, and contractual obligations.

Internal Audits

Internal audits are planned, independent assessments conducted by qualified personnel, for example, the QA Manager, to verify that QMS processes comply with internal procedures and regulatory requirements.

Listed below are the different types of internal audits.

• Scheduled (Routine) Internal Audits: Scheduled internal audits are conducted at planned intervals (e.g. annually or bi-annually) based on a documented, risk-based audit program. High-risk areas, for example, CAPA, complaint handling may be audited more frequently to maintain compliance.
• Ad-hoc Internal Audits: Ad-hoc audits are unscheduled and triggered by specific events such as significant changes. For example, a new sterilization method, or an increase in device malfunctions reported through post-market surveillance. Ad-hoc audits support early detection of potential nonconformities, identify ineffective CAPAs, or trigger risk file revisions.
• Follow-Up Internal Audits: Follow-up internal audits are performed to confirm the closure and effectiveness of actions taken after previous audit findings or major changes. For example, transfer of manufacturing to a new facility.  

External Audits

External audits are formal, independent assessments conducted by entities external to the organization. External audits evaluate the conformity, implementation, and effectiveness of the Quality Management System (QMS) against applicable regulatory requirements, standards, and internal procedures. These audits are performed by external parties, such as notified bodies, regulatory authorities, customers, or authorized representatives.

Listed below are the different types of external audits.

• Regulatory Audits: Regulatory audits are performed by authorities such as the FDA or Notified Bodies to assess conformity with standards like 21 CFR Part 820, EU MDR/IVDR, or MDSAP. Regulatory audits include both scheduled and unannounced audits. Scheduled audits are planned at defined intervals and are part of the routine surveillance or recertification process. Unannounced audits are initiated without prior notice by Notified Bodies or regulators to verify QMS and regulatory compliance under actual operating conditions.
• Supplier Audits: Supplier audits are conducted by medical device manufacturers to evaluate whether critical or high-risk suppliers meet quality and regulatory expectations.

Regulatory Audits

Regulatory audits are official inspections to assess a device manufacturer’s compliance with applicable regulatory requirements. Regulatory audits are performed by regulatory authorities such as the U.S. Food and Drug Administration (FDA), or equivalent Competent Authorities in the EU, for example, the Swedish Medical Products Agency or the Federal Institute for Drugs and Medical Devices (BfArM).

The different types of regulatory audits are listed below.

• FDA Audits: FDA audits are regulatory inspections conducted by the FDA. FDA Audits assess a manufacturer’s compliance with 21 CFR Part 820 (QSR) and other applicable medical device regulations.
• EU MDR Audits: EU MDR audits are conformity assessments performed by EU Notified Bodies. EU MDR Audits verify that a medical device manufacturer’s QMS and technical documentation comply with Regulation (EU) 2017/745.
• EU IVDR Audits: EU IVDR audits are formal assessments conducted by Notified Bodies. EU IVDR audits evaluate whether an in vitro diagnostic (IVD) manufacturer’s QMS, and technical documentation conform to Regulation (EU) 2017/746.
• ISO 13485 Audits: ISO 13485 audits are independent evaluations performed by accredited certification bodies. ISO 13485 audits assess a medical device organization’s conformity to the ISO 13485:2016 standard for QMS requirements.
• Medical Device Single Audit Program (MDSAP) Audits: MDSAP audits are regulatory audits conducted by Authorized Auditing Organizations. MDSAP audits assess a medical device manufacturer’s compliance with ISO 13485 and country-specific requirements for the United States, Canada, Brazil, Japan, and Australia.

FDA Audits

FDA audits (inspections) are regulatory evaluations conducted by the U.S. Food and Drug Administration to assess compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR Part 820 – Quality System Regulation (QSR). FDA Audits apply to U.S.-registered manufacturers of Class I–III devices and related sites involved in design, production, labeling, clinical trials, or distribution.

FDA field investigators conduct inspections, often supported by subject matter experts.

The different types of FDA audits are listed below.

• Routine (Surveillance) Inspections: Routine (surveillance) inspections are periodic inspections, conducted once every 2 years, for Class II and III manufacturers. The purpose of routine inspections is to evaluate ongoing QSR compliance, particularly in management controls, design control, CAPA, production, and process controls, and may also assess compliance with Medical Device Reporting (21 CFR Part 803).
• Pre-Approval Inspections (PAI): Pre-approval inspections are performed before the FDA grants Premarket Approval (PMA). The purpose of pre-approval inspections is to verify that the facility and supporting sites can manufacture the device per QSR.
• Postmarket Inspections: Postmarket inspections are conducted after PMA approval to assess continued compliance with conditions of approval and QMS controls. The purpose of post-approval inspections is to ensure that manufacturing changes, labeling, and supplier updates are properly documented, validated, and, where applicable, reported to FDA.
• For-Cause Inspections: For-cause inspections are triggered by adverse events, MDRs, recalls, or whistleblower allegations and may be limited or expanded to a full QMS review. The purpose of for-cause inspections is to evaluate whether the manufacturer has identified, investigated, and corrected the issue.
• Compliance Follow-Up Inspections: Compliance follow-up inspections verify whether previously cited deficiencies such as FDA 483 observations or Warning Letters are fully addressed. The purpose of compliance follow-up inspections is to confirm the implementation of corrective actions where needed and ensure compliance across affected areas.
• Pre-Market Notification (510(k)) Inspections: 510(k) inspections are not considered routine but may be conducted if concerns impacting substantial equivalence arise. The purpose of 510(k) inspections is to assess QMS readiness under 21 CFR 820 and ensure any changes affecting equivalence are appropriately managed under 21 CFR 807.100. FDA Action on a Premarket Notification.
• Bioresearch Monitoring (BIMO) Inspections: BIMO inspections evaluate compliance with clinical investigation regulations for device trials, including 21 CFR Parts 812 (Investigational Devices Exemption), 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 58 (Good Laboratory Practice for Nonclinical Laboratory Studies). The purpose of BIMO inspections is to verify data integrity, subject protection, and adherence to regulatory requirements by sponsors, investigators, and clinical sites.
• Combination Product Inspections: Combination product inspections are conducted when a product includes a combination of drug, device, or biological components. The purpose of combination product inspections is to verify compliance with 21 CFR Part 4, requiring integration of QSR (21 CFR Part 820) and relevant drug cGMPs (21 CFR Parts 210/211) or biologic cGMPs (21 CFR 600 series).

EU MDR Audits

EU MDR audits are formal conformity assessments conducted by designated Notified Bodies to verify compliance with Regulation (EU) 2017/745, focusing on the QMS, Technical Documentation, and General Safety and Performance Requirements (GSPRs). They apply to manufacturers of Class Is (if sterile/measuring or reusable), IIa, IIb, and III medical devices.

The different types of MDR audits are listed below.

• Initial Certification Audits: Initial certification audits assess the QMS as per Annex IX, Chapter I, and technical documentation as per Annexes II & III during first-time CE marking. The purpose of initial certification audits is to verify that the QMS and the device design, general safety and performance requirements, clinical evidence, and risk management meet MDR requirements.
• Surveillance (Periodic) Audits: Surveillance audits are conducted annually or more frequently based on risk, QMS changes, or previous findings. Surveillance audits verify continued MDR compliance by sampling QMS processes, PMS data, and technical documentation between certification cycles.
• Recertification Audits: Full reassessments performed before CE certificate expiry, at least every 5 years, as per Article 56. The purpose of recertification audits is to verify that QMS compliance, technical documentation, and the device’s benefit-risk profile remain acceptable and up to date.
• Unannounced Audits: Unannounced audits are conducted without notice under MDR Annex IX, at least once every five years or more frequently for high-risk devices. The purpose of unannounced audits is to assess MDR conformity under routine conditions without prior notice.
• Special Audits (“For Cause”): Special audits are triggered by serious incidents, Field Safety Corrective Actions (FSCAs), or significant product or QMS changes. Special audits investigate specific nonconformities or risks that fall outside routine surveillance.
• Technical Documentation Audits (Design Dossier Review): Technical documentation audits are detailed reviews of representative device files per Annexes II and III, covering a device family or product group. The purpose of technical documentation audits is to verify conformity with the requirements of the MDR, in particular, that risk management measures are adequate and that sufficient clinical evidence supports the intended use, safety, and performance claims throughout the entire device lifecycle.

EU IVDR Audits

EU IVDR audits are formal conformity assessments conducted by designated Notified Bodies to verify compliance with Regulation (EU) 2017/746. IVDR audits are applicable to manufacturers of Class B, C, D, and sterile Class A IVDs.

The different types of IVDR audits are listed below.

• Initial Certification Audits (for CE marking under IVDR): Initial certification audits assess the full QMS as per Annex IX and technical documentation as per Annexes II & III for conformity with IVDR requirements. The purpose of initial certification audits is to ensure that IVDs meet applicable regulatory requirements for QMS and technical documentation.
• Surveillance Audits (Periodic): Surveillance audits are scheduled annually or more frequently based on risk. The purpose of surveillance audits is to verify that updates to the QMS, technical documentation, PMS including clinical performance and post-market performance follow-up (PMPF) outputs, and risk management files continue to meet IVDR requirements. This ensures compliance with IVDR requirements between certification cycles.
• Recertification Audits: Recertification audits are performed every five years to reassess the QMS and technical documentation for renewal of CE certification as per Article 51. The purpose of recertification audits is to verify that the QMS and technical documentation remain compliant. This includes ensuring that clinical and performance data continue to support the device’s intended purpose, claims, and benefit-risk profile.
• Unannounced Audits: Unannounced audits are performed without prior notice under IVDR Annex IX, at least once every five years. The purpose of unannounced audits is to evaluate whether conformity is maintained under routine operating conditions. This includes sampling devices or inspecting production records.
• Special Audits (“For Cause”): Special audits are triggered by serious incidents as per Article 82, major QMS changes, or recurring complaints. Special audits investigate specific risks such as post-market deficiencies or supplier issues. The purpose of special audits is to confirm whether the manufacturer has taken effective corrective action and restored full IVDR compliance.

Medical Device Single Audit Program (MDSAP) Audits

MDSAP audits are conducted under the Medical Device Single Audit Program, allowing one audit to meet the requirements of multiple regulatory authorities.

MDSAP audits apply to manufacturers marketing in the U.S. (FDA), Canada (Health Canada), Brazil (ANVISA), Japan (MHLW/PMDA), and Australia (TGA). These audits are performed by Auditing Organizations (AOs) accredited by the MDSAP program and recognized by participating regulatory authorities.

The different types of MDSAP audits are listed below.

• Initial Certification Audit: MDSAP initial certification audits follow a two-stage process: stage 1 assesses QMS documentation and regulatory readiness, while stage 2 evaluates full QMS implementation across core process areas such as management responsibility, measurement and analysis, design and development, and production and service provision. The purpose of initial certification audits is to verify that the QMS is operational, effective, and compliant with ISO 13485 and MDSAP country-specific requirements.
• Annual Surveillance Audits: Annual surveillance audits are performed in years 1 and 2 after certification using a sampling model to evaluate selected QMS processes. The purpose of annual surveillance audits is to verify ongoing compliance and that events like recalls or adverse events are effectively managed.
• Recertification Audits (every 3 years): Recertification audits are full-scope audits conducted every three years to renew MDSAP certification. The purpose of recertification audits is to reassess QMS effectiveness and continued conformity with all MDSAP regulatory requirements.
• Special or Unannounced Audits: Special or unannounced audits are initiated in response to critical issues such as major nonconformities or product recalls. The purpose of special audits is to investigate specific concerns and verify that corrective actions are effective and that regulatory conformity is restored.

ISO 13485 Audits

ISO 13485 audits are third-party assessments of a medical device organization’s Quality Management System (QMS) for conformity to ISO 13485:2016. ISO 13485 audits apply to manufacturers, suppliers, and service providers involved in the design, production, installation, or servicing of medical devices. These audits are performed by accredited third-party certification bodies.

The different types of ISO 13485 audits are listed below.

• Initial Certification Audit (Stage 1 and Stage 2 audits): Initial certification audits include stage 1 which reviews QMS documentation and readiness. Stage 2 is an on-site evaluation of implementation across all applicable processes. The purpose of initial certification audits is to confirm that the QMS is operational, effective, and fully aligned with ISO 13485:2016 for initial certification.
• Annual Surveillance Audits: Annual surveillance audits are scheduled audits performed each year following initial certification, focusing on selected QMS areas based on risk, previous nonconformities, or organizational changes. The purpose of annual surveillance audits is to verify that the QMS remains effective, and compliant with applicable ISO 13485:2016 requirements.
• Recertification Audits (every 3 years): Recertification audits are full-scope audits conducted every three years to renew ISO 13485 certification. The purpose of recertification audits is to confirm the ongoing suitability, adequacy, and effectiveness of the QMS against the entire ISO 13485:2016 standard.
• Special Audits: Special audits are conducted in response to significant organizational or regulatory changes. Examples include facility relocation or scope expansion. The purpose of special audits is to confirm that affected QMS processes remain effective, and compliant with ISO 13485:2016 and applicable regulatory requirements.

Supplier Audits

Supplier audits are evaluations of external parties. This includes contract manufacturers, sterilization providers, and software developers whose services or components impact device quality and regulatory compliance. Supplier audits apply to both critical and non-critical suppliers based on documented risk assessments and are performed by qualified, independent auditors.

The different types of supplier audits are listed below.

• Initial Supplier Qualification Audit: Initial supplier qualification audits are conducted before supplier approval to assess capability and compliance with regulatory requirements. The purpose of an initial supplier qualification audit is to ensure that the supplier can consistently meet product, regulatory, and quality requirements before onboarding. This aligns with the guidance provided in ISO 13485:2016 Clause 7.4.1.
• Routine Supplier Surveillance Audit: Routine supplier surveillance audits are scheduled at defined intervals based on supplier risk level, product criticality, and past performance. The purpose of routine supplier surveillance audits is to verify continued compliance with applicable regulatory requirements and suppliers’ adherence to quality agreements.
• For-Cause Supplier Audit: For-cause supplier audits are triggered by specific risk events such as complaints, adverse events, or performance deviations. The purpose of a for-cause supplier audit is to evaluate whether the supplier’s QMS and controls remain effective and whether re-qualification or risk reclassification is needed.
• Re-Qualification Audits: Re-qualification audits are scheduled or event-triggered assessments of previously approved suppliers, for example, due to changes in product quality. The purpose of re-qualification audits is to verify continued conformance with expected quality and regulatory requirements. This includes adherence to supplier quality agreements or addressing product quality issues.
• Remote Supplier Audits: Remote supplier audits are conducted when on-site access is not feasible or practical (e.g., due to travel restrictions or logistical limitations), or for lower-risk suppliers (e.g., no open critical non-conformities). The purpose of remote supplier audits is to confirm that the suppliers meet all relevant regulatory requirements to a degree equivalent to an on-site audit. This may include virtual facility tours and review of documentation via secure digital platforms.

What are the Audit Requirements for Medical Device Companies?

Audit requirements for medical device companies are defined by ISO 13485:2016, FDA 21 CFR Part 820, EU MDR/IVDR, and MDSAP.

A compliant audit program must demonstrate that the Quality Management System (QMS) is effectively implemented, monitored, and maintains regulatory compliance throughout the product lifecycle.

The following are core areas that are required to be audited for medical device companies.

• Quality Management System (QMS): Audits must verify that the QMS meets requirements outlined in ISO 13485:2016 and applicable regulations such as 21 CFR Part 820 and MDR. These requirements include the establishment of defined quality objectives, effective design and process controls with integrated CAPA and risk management processes, and oversight of outsourced activities. Top management must demonstrate QMS effectiveness per ISO 13485 Clause 5, Management Responsibility.
• Management Review: Audits must confirm that management reviews are conducted as required under ISO 13485 Clause 5.6 and 21 CFR 820.20(c), ensuring that top management evaluates QMS performance, resource needs, and opportunities for improvement based on audit results, CAPA, complaints, and other inputs.
• Design and Development: Audits must evaluate conformity to ISO 13485 Clause 7.3 and 21 CFR 820.30, confirming traceability from user needs to design outputs, verification, validation, and risk management integration. This includes a review of the Design History File (DHF), design changes, and documented design reviews.
• Production and Process Control: Audits must assess production procedures, process validation, environmental controls, and inspection activities as required by ISO 13485 Clauses 7.5 and 21 CFR 820.70. Sampling must confirm traceability, batch records, and documented personnel qualification for critical manufacturing steps.
• Documentation and Record Control: Audits must verify that documents and records such as the DHF, DMR, and DHR are controlled, current, and traceable to regulatory submissions such as 510(k), PMA, or CE Technical Documentation. Records must be version-controlled and retained per regulatory and internal retention policies. Audits should ensure records are complete, and retrievable and support compliance with risk management, design, production, and post-market requirements.
• Audit Scheduling and Execution: Internal audits must follow a documented, risk-based schedule per ISO 13485 Clause 8.2.4, with scope mapped to applicable regulations and high-risk processes. Audit records must include observations, related nonconformities, CAPAs, and documented effectiveness checks.
• Personnel Training and Competence: Audits assess whether personnel affecting product quality or compliance are trained and qualified per defined procedures. Training records must be current, role-specific, and linked to applicable SOPs, work instructions, and regulatory updates.
• Risk Management: Audits must verify the effective implementation of ISO 14971 throughout the device lifecycle. This includes traceability from hazard identification to verification of risk reduction measures. This includes the verification of risk updates from CAPAs, PMS, complaints, or design changes.
• Corrective and Preventive Action (CAPA): Audits must verify that nonconformities, complaints, and audit findings are linked to structured CAPA records, where applicable.  In addition, audits must verify that CAPAs include documented root cause analysis, risk-based prioritization, and completed effectiveness checks.
• Complaint Handling and Regulatory Reporting: Complaint files must include investigation, closure, and escalation as needed, with proper linkage to CAPA and risk files. Audits verify reporting compliance with 21 CFR 803 and MDR Articles 87–89 and verify trending and escalation to FSCA where applicable.
• Supplier Management: Audits must confirm suppliers are qualified, risk-classified, and listed in the Approved Supplier List (ASL) with supporting files including specified requirements, quality agreements, and audit history. Supplier controls must meet ISO 13485 Clause 7.4.1 and 21 CFR 820.50 requirements and MDR Annex VII 4.5.2. a, Annex IX 2.3 and 3.3.
• Labeling and Traceability: Labeling must comply with ISO 13485 Clauses 7.5.1 21 CFR 820.120, and MDR Annex VI, including controlled and approved content, UDI assignment, and printing controls. Audits must verify traceability from raw material to finished product by lot or serial number, including UDI-DI data submissions to EUDAMED (EU) or GUDID (U.S.), as applicable.
• Post-Market Surveillance (PMS) and Clinical Evaluation: Audits must confirm PMS, clinical, and performance evaluation activities comply with MDR Articles 83–86, (detailed in Annex XIV) and IVDR Articles 78–81, (detailed in Annex XIII). All PMS inputs, for example, complaints, FSCAs, or scientific literature must be traceable to reports such as CERs or PERs supporting the device’s benefit-risk conclusions.
• Facility and Environmental Controls: Audits should verify calibration records, maintenance logs, and facility qualifications are complete, current, and linked to applicable standards. Deviations must be documented and escalated through CAPA where applicable.

How to Conduct a Medical Device Audit?

A medical device audit must be conducted by trained auditors as per a documented audit program. A medical device audit must assess both the conformity and effectiveness of the QMS with documented audit criteria, and traceable records, as outlined in ISO 13485:2016 Clause 8.2.4 and 21 CFR 820.22 (for internal audits) and EU MDR Annex IX, Chapter I (for conformity assessments conducted by Notified Bodies). Audits must be executed impartially.

The core steps of a medical device audit are listed below.

1. Conduct the Opening Meeting: Begin with a documented meeting outlining the scope, objectives, and regulatory criteria. For example, ISO 13485, 21 CFR 820, and audit schedule. Confirm access to key QMS records, and SMEs, and define escalation protocols for reporting critical findings.
2. Perform Audit Activities: Execute the audit per a pre-approved plan, and collect objective evidence via interviews, observation of work practices, and document review. Assess compliance with the QMS, verifying processes are effective as documented. Review records for completeness, accuracy, and traceability.
3. Document Audit Observations: Record each observation in real time and classify using a documented scale. The documented scale is defined below.
   • Major: Systemic breakdown. For example, ineffective CAPA results in repeat nonconformities.
   • Minor: Isolated issue with low risk. For example, a missing review signature.
   • Opportunities For Improvement (OFI): Process vulnerability not yet leading to noncompliance. For example, unclear escalation criteria in an SOP.
   • Each observation must cite the exact clause, the affected record(s), and the responsible function, and link to the corresponding NC or CAPA, where applicable.
4. Conduct Daily Wrap-Up Meetings (Multi-Day Audits): Hold daily debriefs to review and validate preliminary findings with QA, clarify evidence gaps, and adjust scope based on unresolved risks. Initiate containment actions immediately if findings indicate quality or safety risks.
5. Conduct the Closing Meeting: Present confirmed findings to QA and process owners, cite clauses, classify severity, and define CAPA expectations, including timelines and effectiveness criteria. Document any audit plan deviations and confirm whether follow-up audits are required.
6. Prepare and Distribute the Audit Report: Generate a controlled audit report with scope, team, clauses assessed, traceable findings, and linked CAPA actions. Ensure approvals follow 21 CFR Part 11, and the report feeds into management review (Clause 5.6) and record control (Clause 4.2.5).

How to Streamline Audit Management for Medical Device Companies

To streamline audit management for medical device companies, consider implementing the following.

1. Implement a Digital Quality Management System (QMS): A validated eQMS streamlines audit scheduling, traceable findings, and CAPA closure by linking audit records to applicable clauses, or SOPs, For example, DHRs and training logs. Audit trail integrity is maintained through time-stamped records, electronic signatures, and workflows compliant with 21 CFR Part 11.
2. Centralize and Standardize Documentation: Centralized, version-controlled documents and predefined templates ensure traceability between procedures, records, and applicable regulations. Centralized storage ensures that only the current, approved versions are used and supports efficient document retrieval during audits.
3. Regularly Conduct Internal Audits: Internal audits must be risk-based, and scheduled, and each audit activity is to be linked to a specific clause, for example, ISO 13485 Clause 8.2.4. Routine internal audits verify QMS effectiveness and ensure readiness for regulatory audits.
4. Leverage Remote and Hybrid Audits: Validated eQMS platforms enable secure remote audits with access to controlled records, screen sharing, and real-time walkthroughs. This supports timely supplier and internal audits while complying with applicable regulatory requirements for remote and hybrid audits. For example, the FDA’s Remote Regulatory Assessment guidance.
5. Conduct Continuous Employee Training: A role-based training matrix ensures that personnel are qualified to perform assigned tasks. Training records must be established and up to date. This ensures audit readiness and compliance with ISO 13485 Clause 6.2 on competence, training, and awareness.
6. Perform Mock Audits: Mock audits simulate real inspections, identify procedural gaps, and assess QMS effectiveness, and CAPA implementation under audit conditions. Audit findings must be documented, classified, and escalated where necessary to improve audit readiness before formal inspections.
7. Optimize Corrective and Preventive Actions (CAPA): An effective CAPA system escalates audit findings into CAPA, where applicable, assigns ownership, and verifies timely closure. This ensures nonconformities are resolved systematically, thereby, reducing repeat findings and minimizing inspection follow-up.
8. Strengthen Supplier Management: Strengthening supplier management streamlines audits by ensuring all qualification records, quality agreements, supplier risk classifications, and supplier-related CAPAs are up to date. They also must be readily accessible during audits.
9. Leverage Data Analytics and Reporting: Integrate audit KPIs such as overdue actions, repeat findings, and CAPA closure times into the QMS. Generate audit reports that enable early identification of high-risk areas that need auditing. Thus, streamlining audit planning by allowing data-driven adjustments to audit scope and frequency.
10. Build an Audit-Ready Culture: An audit-ready culture ensures compliance is maintained during daily operations by maintaining version-controlled records, and clear ownership of quality responsibilities. This reduces the burden of audit preparation, shortens inspection response time, and demonstrates conformity during routine, unannounced, or for-cause inspections.

Can Audit Management Software Streamline Medical Device Audit Processes?

Yes, audit management software streamlines audits by automating planning, execution, and closure in compliance with ISO 13485, 21 CFR 820, and EU MDR/IVDR.

Audit management software improves efficiency and inspection readiness by centralizing audit records traceable to regulatory clauses, controlled documents, and objective evidence, such as CAPA records or test reports.

Listed below are key capabilities of an audit management solution.

• Audit Planning and Scheduling: Create audit plans with defined scope, frequency, and responsible roles. Link individual audits, such as supplier audits or internal audits, to the audit plan and track all audit-related activities.
• Workflow Automation with Role-Based Assignments: ​ Assign audit tasks, and responsibilities, such as the QA responsible and deadlines using predefined workflows with automated reminders to track completion. All changes are automatically recorded in a complete, time-stamped audit trail.
• Integration with CAPA Processes: Escalates audit findings into structured CAPA workflows, where necessary with assigned issue handlers and due dates for completion. This allows efficient tracking and management of CAPA to closure.
• Regulatory-Compliant Audit Trails and Electronic Signatures: Maintains time-stamped, traceable audit logs and electronic signatures in compliance with 21 CFR Part 11 and EU GMP Annex 11. ​
• Centralized Document Control and Retrieval: Store and retrieve audit-related documents through the search function during audits. This ensures efficient document retrieval, and management and demonstrates readiness during audits.
• Supplier Audit Management: Plans and tracks supplier audits and links Supplier Corrective Action Reports (SCARs), where necessary to audit records. This helps ensure efficient supplier management and audit readiness.
• Continuous Improvement Facilitation: Use audit data trends to identify repeat nonconformities and unresolved CAPAs, among others. This supports management review inputs and drives continuous improvement.

SimplerQMS provides medical device QMS software with audit management capabilities. SimplerQMS helps ensure efficient management of quality management processes, facilitating compliance with standards and regulations, including ISO 13485:2016, FDA 21 CFR Part 820, 21 CFR Part 11, EU MDR 2017/745, and IVDR 2017/746. SimplerQMS is a fully validated software in accordance with GAMP 5, significantly reducing the validation burden, supporting compliance with software validation requirements as per ISO 13485 and 21 CFR 820.70(i).

To explore how SimplerQMS can support your organization’s audit readiness, inspection traceability, and overall regulatory compliance, feel free to book a demo.​

How Do Medical Device Audits Differ Compared to Pharmaceutical Audits?

The main difference between medical device and pharmaceutical audits lies in the regulatory frameworks, audit scope, and the types of evidence reviewed to demonstrate product conformity and quality system effectiveness.

Medical device audits are performed according to ISO 13485:2016, FDA 21 CFR Part 820, and EU MDR/IVDR, and focus on management responsibility, resource management including supplier control, design control (Clause 7.3), CAPA, production and process control, risk management (ISO 14971) and post-market surveillance. Auditors frequently review the Design History File (DHF), technical documentation, and risk files to confirm conformity with QMS requirements and alignment with the intended use and clinical performance.

Pharmaceutical audits follow ICH Q10, 21 CFR Parts 210/211, and Good Manufacturing Practice (GMP) compliance. The audit evaluates whether quality systems, manufacturing processes, documentation, data integrity, and product controls ensure the safety, quality, and efficacy of drug products. Key areas of focus include facility conditions, process validation, equipment maintenance, batch record accuracy, cleaning validation, analytical method verification, and CAPA processes including management of deviations and out-of-specification (OOS) results. Auditors assess Master Batch Records, annual product quality reviews, and validated protocols to confirm consistency, reproducibility, and control over formulation, sterility, and product release specifications.