Calibration in the Medical Device Industry: Definition, Requirements, and Process

Calibration in the medical device industry refers to the process of ensuring that measuring, monitoring, and testing equipment provides accurate results. The calibration process is essential for maintaining product quality, patient safety, and regulatory compliance.

Key requirements governing calibration in the medical device industry include FDA 21 CFR Part 820 (U.S.), EU MDR and IVDR (Europe), and ISO 13485:2016. Medical device manufacturers are responsible for performing equipment calibration using traceable standards under controlled conditions and maintaining thorough documentation of all calibration activities. 

To establish a compliant calibration process, organizations must identify the equipment requiring calibration, classify them based on risk, and determine appropriate calibration intervals. The process continues with the creation of standardized procedures, assignment of roles, selection of qualified calibration personnel or providers, scheduling, execution of calibration, recording results, and data review and approval. Secure storage of calibration records and routine internal audits ensures continued compliance and improvement.

Key benefits of a robust calibration program include accurate measurements, regulatory compliance, improved product quality, enhanced traceability, operational risk reduction, and increased stakeholder trust.

Finished medical devices also require calibration to ensure valid results. The manufacturer is responsible for medical device design and providing calibration instructions, while healthcare providers ensure ongoing calibration in the field.

Electronic quality management systems (eQMS) play a pivotal role in streamlining calibration by automating scheduling and facilitating document control. An eQMS reduces human error, enhances regulatory compliance, and integrates calibration activities with broader quality processes such as Corrective Actions Preventive Actions (CAPA), training management, and change control.

SimplerQMS is a fully validated eQMS platform tailored for life science companies. SimplerQMS includes a calibration management module and supports compliance with key requirements. SimplerQMS helps organizations centralize and automate their quality processes, improving operational efficiency and audit readiness.

What Is Calibration in the Medical Device Industry?

Calibration in the medical device industry is the process of ensuring that the equipment used during manufacturing, testing, or monitoring produces accurate and reliable results. Medical device manufacturers are responsible for conducting calibration activities on all equipment that impacts product quality or safety, thus ensuring patient safety and regulatory compliance.

The primary purpose of calibration in the medical device industry is to ensure that measuring, monitoring, and testing equipment perform accurately for its intended use. The calibration process verifies that the equipment operates within acceptable limits or tolerances for its intended use.

The calibration process involves comparing equipment measurements against a known standard that is traceable to national or international standards, when available, under controlled conditions. The equipment is adjusted to align with the standard or properly labeled for service or replacement if nonconformances are found. Calibration results must be properly documented and retained in accordance with regulatory record-keeping requirements.

Any equipment that measures or delivers quantifiable outputs must undergo calibration at defined intervals. Common equipment requiring calibration includes production equipment (e.g., injection molding machines), quality control equipment (e.g., laboratory balances), and environmental monitoring equipment (e.g., thermometers).

Equipment calibration differs from equipment maintenance. Equipment calibration ensures measurement accuracy; equipment maintenance ensures functionality and operational condition. Equipment maintenance focuses on general upkeep, such as lubrication and replacement of worn parts, while equipment calibration verifies measurement validity against certified reference standards. Both equipment calibration and maintenance are essential to keep equipment in proper working order.

Equipment calibration, adjustment, and verification serve distinct roles. Calibration determines accuracy and error in measurement, compared to a known value, without changes in the equipment. Adjustment is making changes or interventions to the equipment to reduce measurement error and align readings with reference values. Verification confirms, using objective evidence, that a device meets predefined requirements. Equipment calibration, adjustment, and verification contribute to equipment compliance and reliability of measurements in medical device manufacturing.

Why Calibration Is Important in Medical Device Manufacturing?

Calibration in medical device manufacturing is important because it ensures the accuracy and reliability of equipment used during production and testing. Equipment calibration safeguards product quality by maintaining measurement accuracy within defined tolerance limits.

Calibration is critical because equipment may degrade due to mechanical wear, prolonged use, or exposure to environmental conditions. Regular calibration verifies measurements against traceable standards and, if necessary, adjusts instruments to restore compliance with specified tolerance limits.

Calibration is mandatory for the medical device industry, according to EU and U.S. regulations and international standards. 21 CFR Part 820 (FDA), EU MDR and EU IVDR (European Commission), and ISO 13485 require documented calibration processes, retention of calibration records, and traceability of activities, including the standards used.

Using uncalibrated or miscalibrated equipment increases the risk of inaccurate or false measurements, non-compliant products, and undetected defects. Such risks compromise patient safety and may lead to product recalls and regulatory non-compliance.

What Types of Equipment Require Calibration in Medical Device Manufacturing?

Calibration in medical device manufacturing applies to all equipment used for measuring, monitoring, or controlling variables that impact product quality, safety, or compliance. The main equipment categories that require calibration are listed below.

• Manufacturing Equipment: Equipment used in production that controls critical parameters affecting product quality, such as temperature, pressure, or time. Examples include temperature controllers on injection molding machines and freeze dryers, as well as cycle timers on automated filling or welding equipment.
• Packaging Equipment: Devices used to seal or label medical devices during packaging, such as heat sealers with temperature control systems, must maintain specific sealing temperatures.
• Laboratory Equipment: Instruments used for testing, analysis, and quality control of raw materials, in-process samples, and finished medical devices. Examples include analytical balances, spectrophotometers, pH meters, and conductivity meters.
• Environmental Monitoring Equipment: Sensors and devices that monitor conditions in controlled areas. Examples are pressure gauges, humidity sensors, and temperature probes that monitor environmental conditions to remain within acceptable ranges.
• Metrology Lab Standards & Reference Equipment: Standards or equipment used to calibrate other equipment, such as reference weights. All standards must be traceable to national or international standards. If such standards are not available, manufacturers shall establish and maintain an in-house standard.

When Should Equipment Be Calibrated?

Equipment should be calibrated at defined intervals based on equipment risk and the manufacturer’s recommendations. Calibration frequency is influenced by several factors, including complexity, measurement sensitivity, criticality of measurements, frequency of use, and the environmental conditions in which the equipment operates, such as temperature fluctuations, humidity, or mechanical vibration. Historical performance data from previous calibrations may also guide the calibration plan.

Signs that equipment may require calibration before its scheduled interval include inconsistent or aberrant measurement results, mechanical malfunction, or visible damage. These signs often indicate that measurement accuracy has drifted outside acceptable tolerance limits, and calibration is necessary.

Regulatory requirements, including 21 CFR Part 820 in the U.S. and EU MDR and IVDR in Europe, mandate that manufacturers maintain a calibration schedule, though they do not specify the frequency. International standards, such as ISO 13485:2016, require calibration to ensure the reliability of equipment measurements throughout the equipment’s lifecycle.

Calibration typically should be performed during installation, after repairs or physical relocation, at predefined, scheduled intervals, and whenever aberrant results are detected. Each of these scenarios may compromise the integrity of the equipment’s measurements, making calibration essential to restore accuracy.

What Regulations and Standards Govern Calibration in Medical Device Manufacturing?

The main regulations and standards that outline equipment calibration requirements in the medical device industry are outlined below.

• FDA 21 CFR Part 820: This U.S. regulation outlines the quality system regulation for medical devices. Section 820.72 of FDA 21 CFR 820 mandates that the inspection, measuring, and test equipment must be suitable for its intended purposes and capable of producing valid results. The manufacturers shall have documented procedures for calibration activities.
• EU MDR: The European Medical Device Regulation (Regulation (EU) 2017/745) sets mandatory quality and safety requirements for all medical devices marketed in the EU. Calibration requirements are included as part of the manufacturer’s quality management system in Annex IX, Chapter I. EU MDR contains clauses also for finished medical devices calibration. More specifically, clause 14.4 of the regulation mandates that devices must be designed and manufactured to allow for safe and effective adjustment, calibration, and maintenance. While clause 23.4 requires manufacturers to provide end users with clear calibration instructions.
• EU IVDR: Regulation (EU) 2017/746 governs in vitro diagnostic devices within the EU market. EU IVDR, like EU MDR, specifies calibration requirements during device manufacturing and testing under Chapter I of Annex IX, which addresses the quality management system. EU-IVDR also contains clauses referring to finished in-vitro diagnostics. According to clause 20.4.1, manufacturers must provide details on preparatory steps or handling of the device before use, including calibration. Clause 13.4 mandates devices to be designed and manufactured in such a way that adjustment, calibration, and maintenance can be done safely and effectively. EU IVDR also mandates requirements for the calibrator, a measurement reference material used in device calibration.
• ISO 13485:2016: This international standard specifies requirements for a quality management system in medical device manufacturing. ISO 13485:2016 in clause 7.6 requires monitoring and measuring equipment to be calibrated or verified, or both, at specified intervals, or before use. The calibration shall be performed against standards that are traceable to international or national measurement standards unless otherwise justified.
• FDA 21 CFR Part 11: FDA 21 CFR Part 11 governs electronic records and electronic signatures. FDA 21 CFR Part 11 applies to records required to be maintained under predicate rules or submitted to the FDA, and the company chooses to use electronic format instead of paper format. Calibration records maintained electronically or electronically signed must comply with FDA 21 CFR Part 11 to ensure data integrity.

Medical device manufacturers often choose to outsource calibration activities to third-party service providers. Calibration service providers must comply with ISO/IEC 17025:2017, the standard specifying general requirements for the competence of testing and calibration laboratories. Compliance with ISO/IEC 17025 demonstrates that the calibration service provider operates competently and produces valid, traceable, and reliable calibration results.

What Are the Key Requirements for Equipment Calibration?

Equipment calibration must follow the requirements below to ensure the reliable performance of equipment and traceability of calibration activities.

• Procedures: Each calibration must follow a documented, standardized procedure tailored to the specific type of equipment. The calibration procedure must include information such as required standards or reference equipment, test points, tolerance limits, acceptance criteria, environmental conditions, and safety precautions.
• Frequency/Scheduling: Calibration must occur at defined and documented intervals based on equipment criticality and risk level, frequency of use, environmental exposure, historical calibration performance, and manufacturer recommendations.
• Qualified Personnel/Third-Party Contractor: Only trained and authorized staff or qualified service providers may perform calibration. When using third-party contractors, organizations must verify the provider’s qualifications and should seek accreditation to ISO/IEC 17025.
• Traceability: All standards used must be traceable to national or international standards or justified when such standards are unavailable. Calibration records must include dates, results, and the identity of personnel who performed the calibration.
• Documentation and Certificates: Every calibration event must result in a certificate, documenting parameters such as equipment ID, calibration date, measured values, pass/fail status, measurement uncertainty, and traceability information. The calibration certificate must be signed and stored securely for reference. Calibrated equipment should be clearly labelled with calibration status, date of calibration, due date, and equipment ID.
• Non-Conformance Handling: Any equipment found outside tolerance limits must be quarantined, and a quality investigation must be performed. In the context of quality investigation, a risk assessment shall be conducted for the impact of the out-of-tolerance results on product quality. Corrective actions must be taken to restore accuracy and prevent similar events in the future.
• Change Management: Any change to calibration procedures, intervals, or acceptance criteria must be reviewed and approved under a formal change control process. The rationale and impact must be documented.
• Audit Readiness: Calibration records must be easily accessible, clearly organized, and readily retrievable during regulatory inspections or external audits. Incomplete or missing records indicate non-compliance.
• Data Integrity: When calibration records are managed through paper-based records, organizations must establish documented procedures to control access, prevent unauthorized changes, and ensure traceability and legibility of entries to uphold data integrity. When calibration records are managed electronically, systems must comply with FDA 21 CFR Part 11. Electronic records must have access restrictions and include controls for electronic signatures to ensure data integrity.

What Is the Equipment Calibration Process?

The steps of the medical equipment calibration process are listed below.

1. Identify All Equipment Requiring Calibration: List all instruments and equipment used for measuring, monitoring, or controlling parameters that impact product quality, safety, or compliance.
2. Classify Equipment by Risk and Function: Categorize equipment based on how measurement errors could affect product performance or patient safety.
3. Determine Calibration Frequency: Set calibration intervals using manufacturer recommendations, risk level, and operating conditions.
4. Define Calibration Procedures: Create written procedures for each device type, detailing calibration steps, test points, standards, acceptance criteria, and safety measures.
5. Assign Roles and Responsibilities: Define who is responsible for planning, executing, documenting, and reviewing calibration activities.
6. Select Calibration Service Providers or Personnel: Use in-house trained personnel or qualified external providers to ensure competency.
7. Schedule Calibration Activities: Maintain a master calibration schedule, ensuring no equipment exceeds its calibration due date.
8. Perform Calibration According to Procedures: Follow defined procedures using traceable reference standards.
9. Record Calibration Results: Generate the calibration certificate with the date, results, technician identity, and standards used. Document actual readings and any nonconformances or corrective actions.
10. Review and Approve Calibration Data: Verify the results against acceptance criteria and approve records within the quality management system before using the equipment.
11. Label Calibrated Equipment: Apply a calibration label to the calibrated equipment, stating equipment ID, calibration status, calibration date, and calibration due date.
12. Store Calibration Records Securely: Maintain electronic or physical storage systems that allow quick retrieval and protect data from alteration or loss.
13. Audit the Calibration Program Regularly: Conduct internal audits to verify compliance, identify gaps, and initiate corrective actions as needed.

1. Identify All Equipment Requiring Calibration

Identify all equipment requiring calibration by reviewing all equipment and instruments used for measuring, monitoring, or controlling critical parameters during manufacturing, testing, packaging, and environmental control. Focus on equipment where measurement or reading errors may impact product quality, process control, or patient safety.

Start by documenting equipment across all departments, production, quality control, laboratories, and cleanrooms, and compile an inventory. For example, a balance used in the quality control department, or a data logger monitoring storage conditions, should be included. Include equipment ID, location, make/model, function, and current calibration status. Identification of equipment requiring calibration supports traceability of calibration activities and prevents the use of miscalibrated equipment.

2. Classify Equipment by Risk and Function

Classify equipment by risk and function to prioritize calibration activities and allocate resources effectively. Group equipment based on their role in the process and assess the risk associated with inaccurate measurements. Consider factors such as the impact on product quality, patient safety, regulatory compliance, and process control. Failure Modes and Effects Analysis (FMEA) can be used as a risk management tool to identify, assess, and mitigate potential failure modes associated with equipment calibration.

Equipment directly influencing product specifications, like sterilization temperature probes, carries a higher risk than auxiliary apparatus. Risk-based classification supports the determination of calibration frequency. High-risk equipment may require more frequent calibration due to tighter tolerance requirements and critical functions. A risk-based approach can ensure compliance while optimizing calibration efforts.

3. Determine Calibration Frequency

Determine calibration frequency based on equipment risk classification, frequency of use, and the manufacturer’s recommendations. High-risk or frequently used equipment requires shorter intervals to prevent measurement drifting.

Manufacturer’s recommendations often specify baseline intervals, but these should be adjusted when historical performance data shows early drift or when equipment is exposed to harsh environmental conditions. While regulations and standards do not impose fixed calibration frequencies, they do require a documented rationale for the selected frequency. A well-defined calibration interval ensures measurement reliability and maintains patient safety, without unnecessary equipment downtime and costs.

4. Define Calibration Procedures

Define calibration procedures by creating standardized, written procedures tailored to each type of equipment. Calibration procedures must specify the steps for performing calibration, including setup, reference standards with valid traceability, measurement points, acceptance criteria, environmental conditions, actions for out-of-tolerance results, and safety precautions. Ensure all procedures align with the manufacturer’s instructions, regulatory expectations, and internal quality requirements.

Calibration procedures must be detailed enough to ensure consistency, reproducibility, and compliance across different personnel or service providers. Well-defined procedures reduce variability and human error, especially when calibrating complex or high-risk equipment.

5. Assign Roles and Responsibilities

Assign roles and responsibilities to clearly define who is accountable for planning, executing, reviewing, and approving calibration activities. Responsibilities must be distributed across technical personnel, quality assurance, and management to ensure proper oversight and execution. Designating specific roles helps avoid gaps, duplication, or confusion during the process.

Ensure that all individuals have appropriate training to perform their duties. Only trained and authorized personnel should perform calibration activities, whether in-house or through qualified external providers.

Clear role assignments also support audit readiness, as inspectors will expect defined responsibilities with documented evidence of personnel competency and task ownership. For example, the quality assurance team may review and approve calibration data, while trained technicians conduct the actual measurements. Defining responsibilities also ensures timely calibration, proper response to out-of-tolerance findings, and readiness during audits.

6. Select Calibration Service Providers or Personnel

Select qualified calibration service providers or properly trained internal personnel to ensure that all calibration activities meet technical and competency requirements. External providers should preferably hold accreditation to ISO/IEC 17025, confirming their competence in performing calibrations using appropriate methods and standards. For in-house personnel, documented training and ongoing competency assessments are essential.

Using qualified providers or skilled staff reduces the risk of invalid calibration, which could lead to product non-conformance, patient safety issues, or regulatory violations. Ensure that both in-house personnel and external service providers follow equivalent procedures and meet the same documentation requirements to maintain consistency and audit readiness.

7. Schedule Calibration Activities

Schedule calibration activities to ensure all equipment is calibrated within its defined interval, maintaining measurement accuracy and compliance. The schedule must be integrated into the facility’s maintenance and calibration program and quality management system to ensure visibility, timely reminders, and accountability.

Maintain a calibration plan and include the equipment ID, last calibration date, calibration frequency, next calibration date, and assigned personnel or service provider. An eQMS serves as a centralized system to track due dates, manage notifications, and prevent overdue calibrations.

To accommodate operational needs and resource availability, calibration schedules may include a tolerance window around the nominal due date, for example, ±15 days for a six-month calibration. This flexibility of the tolerance window allows organizations to manage workload and minimize equipment downtime without compromising compliance. The tolerance window should be formally documented in the calibration procedure with technical justification based on risk and operational requirements. A structured schedule helps ensure continuous measurement accuracy while aligning with regulatory and operational expectations.

8. Perform Calibration According to Procedures

Perform calibration according to documented procedures to ensure consistency, accuracy, and compliance. Follow each defined step precisely, using the specified reference standards, environmental conditions, and acceptance criteria. Only trained and authorized personnel should execute the calibration, and all tools and reference standards used must be in a valid calibration status.

Strict adherence to procedures ensures measurement results are reliable and traceable. Performing calibration as instructed minimizes variability and human error, which is important in regulated environments. Any non-conformance must be addressed following the relevant procedure for non-conformance management.

9. Record Calibration Results

Record calibration results at the time of completion of the calibration activity to ensure data integrity. Include measured values, standards used with traceability information, calibration date, instrument ID, pass/fail status, any adjustments made, and the name and signature of the person performing the calibration. Use controlled forms that are part of the quality management system to document the calibration results.

Accurate and complete records provide evidence of compliance and support investigation, in case any non-conformance occurs. For example, if equipment was found out of tolerance and adjusted, both the pre-adjustment and post-adjustment values must be recorded. A quality investigation should follow to determine the root cause of failure and whether the equipment failure impacts the quality of any batch produced or tested during the affected period.

10. Review and Approve Calibration Data

Review and approve calibration data to verify its completeness, accuracy, and compliance with defined acceptance criteria. The review must be conducted by authorized personnel independent of the individual who performed the calibration.

Calibration data review includes verifying that the calibration was performed correctly, checking that all measured values are within tolerance limits, ensuring any non-conformances are properly documented, and that appropriate investigations have been initiated.

Approval of the calibration data ensures that only properly calibrated equipment is released for use and that any instruments found to be out-of-tolerance are removed from operation until corrective actions are completed. For example, if a temperature sensor fails to meet defined limits, the reviewer must confirm that it was removed from service and that an impact assessment of affected products or processes was conducted.

11. Label Calibrated Equipment

Label calibrated equipment after calibration to indicate the equipment’s current calibration status. The label must include the calibration status, the calibration date, the due date, and the equipment ID. If applicable, include the calibration status via color codes, for example, use a red label for equipment that has failed calibration.

Clear labeling prevents the accidental use of out-of-calibration or non-compliant equipment in manufacturing, testing, or monitoring processes. Labeling also helps during audits and inspections by providing visible confirmation that equipment is properly maintained.

12. Store Calibration Records Securely

Store calibration records securely to preserve data integrity, ensure traceability, and support regulatory inspections. Records may be stored electronically in compliance with FDA 21 CFR Part 11, or within a protected physical archive with restricted access.

Each record must be easily retrievable, protected against unauthorized alteration, and linked to the corresponding equipment’s calibration history.

Secure storage enables rapid access during audits or investigations and protects against data loss or tampering. An eQMS can organize calibration certificates by device ID, calibration date, and responsible personnel, with audit trails capturing every modification.

Proper storage of calibration records ensures long-term availability of evidence confirming that equipment has been maintained in a calibrated and compliant state.

13. Audit the Calibration Program Regularly

Audit the calibration program regularly to verify compliance with internal procedures, regulatory requirements, and quality standards. Audits should assess whether calibration activities are performed within scheduled intervals, documented correctly, reviewed properly, and supported by complete and traceable records. The audit must also evaluate the effectiveness of risk-based scheduling, the competency and qualifications of calibration personnel, and adherence to approved procedures.

Regular audits help identify process gaps, recurring non-conformities, or outdated practices. For example, an internal audit may reveal that several low-risk devices exceeded their calibration tolerance window due to scheduling oversight, prompting corrective actions.

Documented audit findings support continuous improvement and demonstrate control of the calibration system during regulatory inspections.

What Are the Benefits of a Robust Calibration Program?

A robust calibration program ensures that all measurement equipment used in medical device manufacturing and testing remains accurate and compliant. The main benefits of a robust calibration program are given below.

• Ensures Measurement Accuracy: Reduces risk of incorrect measurements by confirming equipment performs within defined tolerance limits.
• Strengthens Customer and Stakeholder Trust: Demonstrates control over measurement systems and processes that affect product performance and patient safety.
• Supports Regulatory Compliance: Fulfills calibration requirements outlined in FDA 21 CFR Part 820, ISO 13485, and EU MDR, among others.
• Improves Product Quality: Prevents defects by using properly calibrated equipment in manufacturing and testing processes.
• Enhances Traceability and Documentation: Maintains complete calibration records for audit readiness and investigation of measurement-related issues.
• Reduces Operational Risk: Mitigates failures caused by undetected equipment drift or out-of-tolerance conditions.
• Optimizes Equipment Reliability: Identifies performance trends that inform proactive maintenance and replacement planning.

What Are the Calibration Requirements for Finished Medical Devices?

Calibration requirements for finished medical devices ensure the device performs within specified accuracy and reliability limits throughout its intended use. This ensures patient safety and regulatory compliance.

For equipment used in medical laboratories, ISO 15189:2022 applies. According to ISO 15189:2022, the laboratory shall have procedures for the calibration of equipment that directly or indirectly affects examination results. Clinical laboratories, operating under FDA 42 CFR Part 493 (CLIA), shall have documented procedures and evidence of calibration for high and moderate complexity tests. 

Medical equipment must be calibrated to maintain diagnostic accuracy and prevent incorrect test results or treatment errors. Calibration ensures that devices such as infusion pumps, blood pressure monitors, or medical laboratory equipment operate within defined measurement tolerances, minimizing the risk of patient harm due to inaccurate outputs.

Calibration directly impacts patient safety by ensuring devices provide consistent, accurate readings for diagnosis, monitoring, and treatment. Healthcare facilities play a critical role in maintaining the calibration of equipment used during care delivery. This includes scheduling routine calibration by trained personnel, maintaining records, and removing equipment from service if calibration is overdue or fails.

Responsibility for ensuring that finished medical devices are calibrated is shared between the device manufacturer and the healthcare facility or clinical laboratory. The manufacturer is responsible for designing devices to allow safe and effective calibration, defining the calibration method and interval, and providing clear calibration instructions to the user. The responsibilities of the device manufacturer regarding finished device calibration are described in the EU MDR and EU IVDR. Calibration risks such as drift or missed intervals are addressed during design risk management, in accordance with standards such as ISO 14971. During post-market surveillance, calibration-related failures or complaints are monitored, and corrective actions are taken, as required.

The healthcare provider or clinical lab is responsible for implementing the calibration as instructed, documenting the process, and ensuring the device remains safe and effective in the field. Together, both parties ensure ongoing compliance and performance of the medical device throughout its lifecycle.

How Does Calibration Differ in the Medical Device Industry and Pharmaceutical Industry?

Calibration in the medical device industry differs from the pharmaceutical industry due to the nature of products, regulatory requirements, and types of equipment used. While both sectors demand accurate measurements, calibration in the medical device industry often extends beyond production equipment to include the finished medical devices used by healthcare providers.

The calibration requirements in the medical device industry cover manufacturing and testing equipment, as well as finished devices. Devices like patient monitors and infusion pumps require calibration even after leaving the manufacturing site to maintain performance in clinical settings. Regulations like 21 CFR Part 820, EU MDR, and standards such as ISO 13485 describe the framework for calibration in the medical device industry.

Calibration in the pharmaceutical industry focuses on manufacturing and laboratory equipment such as tablet compression machines and HPLCs. Regulatory requirements, like 21 CFR Part 210 and 211 and EU GMP, mandate calibration of equipment to ensure consistent quality of medicinal products.

What Is the Role of eQMS in Streamlining Calibration Activities?

The role of an eQMS is to centralize and automate calibration management activities to ensure equipment accuracy, compliance, and traceability. An electronic quality management system digitizes quality processes, including calibration scheduling, record-keeping, approvals, and notifications, reducing reliance on manual tracking or spreadsheets.

An eQMS supports calibration management by automating recurring tasks such as scheduling based on predefined intervals and sending alerts before due dates. An eQMS ensures all calibration records are traceable, verifiable, and compliant with audit trail requirements. Built-in workflows route calibration data for review and approval, enforce role-based access, and protect records from unauthorized changes, directly reducing human error and supporting audit readiness.

Key features of eQMS, such as integrated document control, automated reminders, and linked equipment histories, streamline calibration workflows. Centralized dashboards provide visibility across all calibration activities, allowing quick status checks and overdue alerts.

Integrating calibration activities into eQMS ensures complete traceability and supports regulatory alignment, particularly for life science companies governed by FDA 21 CFR Part 820, EU MDR, and related frameworks. An eQMS connects calibration records to broader quality activities like change control, CAPA management, and training management, creating a unified system of records.

SimplerQMS offers a fully validated medical device eQMS, compliant with ISPE GAMP5, specifically designed for life science companies. SimplerQMS complies with FDA 21 CFR Part 11, meeting the requirements for computerized systems. SimplerQMS includes a calibration management module as part of a broader quality management system software, which spans document control, change control, CAPA management, audit management, and more. SimplerQMS supports compliance with FDA 21 CFR Part 820, EU MDR, EU IVDR, ISO 13485, and other life science regulations and standards.