Quality Assurance (QA) is a framework for ensuring the quality of products and services through a systematic approach. Medical device QA is the systematic approach implemented to ensure that medical devices are of uniform and high quality throughout their lifecycle.
QA encompasses establishing processes and procedures for medical devices to consistently meet quality specifications and comply with customer and regulatory requirements.
To conduct QA activities systematically, medical device companies implement a quality assurance system. The medical device QA system ensures the quality of products or services and compliance with internal, customer, and regulatory requirements.
Differentiating between QA and Quality Control (QC) is essential as they serve distinct roles in maintaining and ensuring product or service quality. QA focuses on ensuring quality, while QC is concerned with testing and controlling the quality of products or services.
Medical device QA is an integral component of the Quality Management System (QMS) and shares the same quality processes. The processes of a medical device QA system include document management, training management, change control, audit management, supplier management, and others.
Quality management software streamlines and automates the processes of a medical device QA system.
SimplerQMS provides a QMS software solution designed for life science companies, including those within the medical device industry. Book a personalized demo today to experience how SimplerQMS can streamline your QA system processes.
This article discusses the following topics in more detail:
- What Is Quality Assurance (QA) in Medical Device Industry?
- Why Is Medical Device Quality Assurance Important?
- What Are the Processes of a Medical Device Quality Assurance System?
- What Is the Difference Between Medical Device Quality Assurance and Quality Control?
- What Is the Role of QMS Software in Supporting Medical Device QA System Processes?
What Is Quality Assurance (QA) in Medical Device Industry?
Quality Assurance (QA) in the medical device industry is the framework and systematic approach implemented to ensure the quality of medical devices.
The primary goal of quality assurance in the medical device industry is to ensure medical devices are safe, effective, and reliable for their intended use.
Medical device QA encompasses a comprehensive set of activities and processes that ensure medical devices meet quality, safety, and performance specifications, as well as comply with all relevant requirements.
Why Is Medical Device Quality Assurance Important?
Medical device quality assurance is important to ensure medical devices are of uniform and high quality.
The purpose of QA in the medical device Industry is to systematically ensure that devices consistently meet quality specifications and relevant requirements through their lifecycle, from development to post-market.
The main function of a medical device QA system is to establish and enforce comprehensive processes and procedures that ensure product safety, efficacy, and reliability. Medical device QA includes establishing quality specifications, creating procedures, maintaining accurate documentation, monitoring Key Performance Indicators (KPIs), and other activities.
What Are the Processes of a Medical Device Quality Assurance System?
A medical device quality assurance system comprises, among others, twelve primary processes, as described below.
Medical device QA system processes are integral components of the medical device quality management system (QMS). The medical device QMS comprises a set of processes aimed at ensuring the consistent quality and control of devices in compliance with internal, customer, and regulatory requirements.
- Design Control: Systematic process that manages the creation and validation of device designs to ensure they comply with quality specifications and relevant requirements.
- Product Management: Process to implement procedures and controls to ensure consistent product quality and compliance throughout the medical device lifecycle.
- Document Management: Process to organize and control documentation to ensure traceability and compliance with relevant requirements.
- Training Management: Process to create, schedule, assign, and track training programs to ensure personnel is competent in handling relevant processes.
- Change Control: Systematic process to control and record changes to maintain quality and compliance.
- Equipment Management: Process that oversees the calibration and maintenance of equipment used in device manufacturing to ensure accuracy and reliability.
- Audit Management: Process to plan, conduct, and report audits to assess compliance with internal, customer, and regulatory requirements.
- Supplier Management: Systematic process to qualify and monitor suppliers to ensure they meet quality specifications and deliver compliant materials and components.
- Nonconformance Management: Process to identify, investigate, and resolve events where products or processes fail to meet quality specifications or relevant requirements.
- CAPA Management: Process to identify, correct, and prevent issues through systematic investigation, corrective actions, and preventive actions.
- Complaint Management: Systematic process that handles and resolves customer complaints.
- Post-Market Surveillance (PMS): Systematic process to monitor medical devices after they have been released to the market.
The following sections elaborate on each medical device QA system process and provide examples of how SimplerQMS software streamlines each process.
Design Control
Design control is a systematic process implemented during the development of medical devices to ensure that the final product meets user needs, intended uses, quality specifications, and relevant requirements. Medical device design controls involve planning, reviewing, verifying, validating, and documenting procedures.
SimplerQMS design control capabilities streamline the management of multiple documents in the Technical Files (TF), Device History Records (DHR), Design History Files (DHF), and Device Master Records (DMR). The eQMS enables exporting documents and document collections to local storage, facilitating sharing with partners, and preparing regulatory submissions. SimplerQMS enables the linking of medical device designs to specific requirements, simplifying audits, inspections, and regulatory submissions.
Product Management
Product management is the process of managing and overseeing the entire lifecycle of a medical device, from design and development through distribution and post-market. Product management involves defining product specifications, coordinating development activities, managing production, and supporting product post-market activities.
Product management helps ensure that medical devices comply with quality specifications and relevant requirements. Product management includes quality inspections, testing, and validation to ensure the final product is safe, effective, and of uniform and high quality.
SimplerQMS offers a centralized repository for all product-related information, including device design, specifications, market research, and regulatory submissions, among others. SimplerQMS product management module encompasses customizable fields to personalize product lot numbers and other information to match existing definitions.
Document Management
Document management is the systematic process of managing and overseeing the creation, review, approval, storage, distribution, and retirement of documents. Document management involves ensuring version control, maintaining revision history, ensuring traceability, and helping achieve compliance with relevant requirements.
Effective document management ensures that all relevant documents, such as design specifications and manufacturing procedures, are properly created, reviewed, approved, and retired. The document management process ensures the availability of accurate and up-to-date information throughout the medical device’s lifecycle.
The SimplerQMS document management module streamlines document creation, review, approval, storage, and retirement. The QMS software provides capabilities for electronic signatures, controlled printing, and time-stamped audit trails to help ensure regulatory compliance and improve document traceability and accessibility.
Training Management
Training management is the process of managing training and competency development to ensure employees have the necessary knowledge and skills to perform their duties effectively. Training management involves scheduling training sessions, tracking completion, assessing competency, and maintaining training records.
Training management ensures that personnel involved in all medical device lifecycle stages receive sufficient training and demonstrate competence. Training management helps maintain uniform and high product quality and regulatory compliance by ensuring that all staff are knowledgeable about current procedures, tasks, and requirements.
SimplerQMS streamlines the creation and management of training plans, quiz assignments, competency assessments, and training records for relevant personnel. The training management module in SimplerQMS monitors training completion and certification statuses. The eQMS sends reminders for upcoming training assignments, ensuring continuous qualification and competence among employees in their respective roles.
Change Control
Change control is the systematic process of managing and overseeing all changes made to documents, products, procedures, work instructions, and processes. Change control ensures changes are introduced in a controlled and coordinated manner.
Effective change control ensures that any modifications are evaluated, approved, and recorded properly. The change control process helps maintain product consistency, compliance with relevant requirements, and the quality of the medical devices.
SimplerQMS software offers predefined workflows for initiating, reviewing, approving, and implementing changes. SimplerQMS change management module creates change records with time-stamped audit trails and informs relevant employees of change control tasks through notifications and reminders.
Equipment Management
Equipment management is the process of managing and controlling equipment calibration, maintenance, and validation. Equipment management involves scheduling calibrations, performing maintenance, tracking equipment usage, and documenting all activities.
Equipment management ensures that all machinery and instruments are functioning correctly and accurately. Equipment management minimizes the risk of equipment-related errors, helping ensure consistent product quality.
SimplerQMS equipment management module simplifies equipment calibration and maintenance processes through features that allow scheduling, tracking, and recording of calibration and maintenance activities. The eQMS facilitates the identification of quality-critical equipment, allows the establishment of calibration schedules, records results, tracks equipment history and helps manage inventory more effectively.
Audit Management
Audit management is the process of managing internal, supplier, customer, and external audits to ensure compliance with standards, regulations, and other relevant requirements. Audit management involves planning audits, conducting audits, and documenting findings.
Effective audit management ensures that all processes and quality systems comply with internal quality specifications and customer and regulatory requirements. Regular audits identify areas for improvement, ensuring continuous improvement of quality.
SimplerQMS provides capabilities for planning, scheduling, conducting, and documenting audits and inspections. SimplerQMS audit management module enables the creation of audit checklists, assignment of audit tasks, and documentation of audit findings. The QMS software integrates with all QMS modules to facilitate the relation of, for instance, audit findings with products, equipment, and personnel and streamline the escalation of audit findings to the CAPA process.
Supplier Management
Supplier management is the systematic process of managing and overseeing relationships with suppliers to ensure the quality and compliance of sourced materials, components, and services. Supplier management involves qualifying suppliers, monitoring performance, and managing contracts, among other activities.
Supplier management ensures that all materials and components sourced from suppliers meet quality and safety specifications and relevant requirements. Supplier management helps maintain the overall quality and compliance of the final product.
The SimplerQMS supplier management module supports medical device companies in maintaining a reliable approved suppliers list (ASL) and identifying quality-critical suppliers. The QMS software automatically sends reminders and notifications for supplier-related tasks as scheduled.
Nonconformance Management
Nonconformance management is a process that identifies, documents, investigates, and addresses events where medical devices or processes do not meet quality specifications and customer and regulatory requirements.
Effective nonconformance management ensures that nonconformances are promptly identified and corrective actions implemented. Nonconformance management facilitates the implementation of preventive actions to avoid recurring issues.
SimplerQMS offers a nonconformance management module with predefined workflows for efficiently documenting, reviewing, investigating, and resolving issues throughout the medical device lifecycle. The eQMS seamlessly integrates QMS processes, such as CAPA management, to ensure comprehensive issue resolution.
CAPA Management
CAPA management is the process of managing and overseeing corrective and preventive actions to resolve issues and prevent recurrence. CAPA management involves identifying issues, conducting root cause analysis, implementing corrective and preventive actions, and performing effectiveness assessments.
CAPA Management ensures that issues are thoroughly investigated and corrective and preventive actions are implemented. CAPA management helps improve medical device quality and reduces the probability of future nonconformances.
The CAPA management module in SimplerQMS offers tools for initiating CAPAs directly from recorded issues, such as nonconformances, deviations, complaints, and audit findings. The QMS software simplifies creating and implementing corrective and preventive actions, tracking CAPA progress, and assessing the CAPA effectiveness.
Complaint Management
Complaint management is the systematic process of controlling the recording, investigation, and resolution of complaints, feedback, and suggestions of product users regarding product quality or performance. Complaint management involves recording complaints, investigating complaints, implementing solutions, and communicating resolutions.
The primary purpose of complaint management is to promptly address concerns raised by the users of the product or service. Complaint management helps identify potential issues, implement corrective actions, and increase customer satisfaction.
The SimplerQMS complaint management module simplifies the recording, monitoring, and resolution of complaints while supporting seamless communication across departments. SimplerQMS provides a centralized repository for all complaints, feedback, and suggestions, improving accessibility and ensuring prompt responses and resolutions with automated notifications and reminders.
Post-Market Surveillance
Post-market surveillance (PMS) is the systematic process of managing and overseeing the monitoring of medical devices after they have been released to the market. Post-market surveillance involves collecting and analyzing data on device performance, identifying potential safety issues, reporting adverse events, and implementing corrective and preventive actions.
PMS helps ensure that any potential issues or adverse events are identified and addressed promptly, maintaining device quality, safety, effectiveness, and compliance.
SimplerQMS offers features that support managing PMS by enabling companies to handle all documentation in a single repository, ensuring documents are easily accessible. The eQMS simplifies the process of relating PMS documents to products, processes, equipment, suppliers, CAPAs, audits, and more. SimplerQMS allows the creation of document collections to facilitate regulatory audits, streamlining the audit process and ensuring all necessary information is readily available.
What Is the Difference Between Medical Device Quality Assurance and Quality Control?
The main difference between Quality Assurance (QA) and Quality Control (QC) in the medical device industry lies in their focus and scope.
Medical device QA is a framework supported by systematic approaches that ensure the uniform and high quality of medical devices.
Medical device QC encompasses the procedures used to test and control the quality and performance of devices throughout their lifecycle.
Both QA and QC are essential components of a comprehensive quality management system (QMS) in the medical device industry. QA, QC, and QMS work together to ensure that devices are high-quality, safe, and effective and comply with relevant requirements.
The illustration below represents the relationship between QA, QC, and QMS.
What Is Medical Device Quality Control (QC) System?
A medical device quality control system is a suite of processes, procedures, and work instructions for testing and controlling the quality of medical devices.
The purpose of a medical device QC system is to ensure the quality, safety, efficacy, and reliability of medical devices. The QC system ensures that medical devices meet predefined specifications and perform as intended by systematically testing and inspecting devices at all stages of their lifecycle.
Medical device companies implement a medical device QC system to ensure products and services meet quality specifications and relevant requirements.
What Is the Role of QMS Software in Supporting Medical Device QA System Processes?
Quality Management System (QMS) software, often referred to as eQMS, supports QA system processes in the medical device industry by streamlining and automating QA activities. The eQMS helps ensure compliance with internal, customer, and regulatory requirements.
SimplerQMS provides an effective eQMS designed specifically for life science, including the medical device industry. Our medical device QMS software offers a comprehensive platform for managing and optimizing quality assurance activities throughout the medical device lifecycle.
SimplerQMS supports all quality processes, such as document management, training management, change control, equipment management, audit management, supplier management, nonconformance management, and others.
SimlperQMS offers comprehensive QMS process support, helping companies comply with life science requirements, including ISO 13485:2016, FDA 21 CFR Part 11 and 820, MDR, IVDR, EU Annex 11, and others.
SimplerQMS software is fully validated in accordance with ISPE GAMP 5. All software validation processes are handled by SimplerQMS, lessening customers from the need to spend extra resources, time, or costs toward software validation.
Learn how SimplerQMS can streamline your quality assurance processes. Book a personalized demo and talk with our Quality Solution experts to understand how SimplerQMS can support your company.
