Introduction to quality in medical devices
In medical devices, quality refers to the degree to which a device meets specifications, requirements and standards.
The purpose of quality is to ensure the safety, efficacy, and reliability of medical device products. This includes ensuring the device performs its intended function accurately and consistently and does not pose unacceptable risks when used as intended over its expected lifespan. Quality is essential to comply with regulatory standards and guidelines set by authorities, including ensuring consistent production processes that adhere to good manufacturing practices (GMP). As with most aspects of medical device development, quality processes continue throughout the device’s lifecycle.
Quality is achieved through quality management, quality assurance and quality control.
Quality management
Quality management refers to an organisation’s overall system and framework to ensure its products meet the necessary quality standards. It encompasses all quality aspects, including planning, control, assurance, and improvement.
A Quality Management System (QMS) is a structured system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. Standards like ISO 13485:2016 describe the requirements for a QMS specifically designed for medical devices. There are some fundamental principles that underly QMS requirements, including:
- Continuous improvement: Processes should be implemented to improve ongoing product quality and operational efficiency throughout the product lifecycle and the organisation’s development.
- Leadership and commitment: Top management must promote a quality culture within the organisation and take responsibility for planning, implementing and monitoring the QMS.
Quality assurance and quality control are essential components of a quality management system. While they are complementary, they fulfil distinct roles and have different objectives.
Quality assurance (QA)
Quality assurance (QA) is a subset of quality management focused on ensuring that quality requirements will be fulfilled. QA focuses on processes. It is a proactive approach to planning systematic activities to ensure products are developed and manufactured according to specified requirements. The aim is to proactively analyse processes and take action to prevent non-conformities throughout the product manufacturing lifecycle.
QA is not a single procedure or tactic. It involves many different approaches, including verification and validation activities to confirm that the product meets design specifications and performs as intended, as well as monitoring and controlling processes to ensure consistency in development and manufacturing. QA also involves maintaining thorough records of processes, tests, and inspections to demonstrate compliance and traceability. Regular inspections and audits ensure adherence to regulatory standards and internal procedures. Combined, these activities identify process flaws that lead to ineffectiveness or inefficiency. They should also ensure that processes maintain compliance with externally imposed regulatory and internal requirements. The goal of QA is the continuous improvement of processes, leading to improved production and quality management.
Quality control (QC)
Quality control (QC) identifies product defects after manufacturing but before being distributed to the market. QC focuses on products and is reactive. It involves testing individual products or batches to determine if they meet the required specifications or if any deviations are present. The objective is to detect faulty products before they reach the end user.
Conclusion
Quality assurance and quality control activities are conducted through various quality management processes. While QA teams may use a quality management system as a tool to ensure quality, the scope of QMS processes extends beyond just QA and QC functions. The QMS is an organisation’s internal rulebook, a collection of policies, processes, and procedures that govern how the organisation develops and manufactures medical device products.
Resources
MedDev Central Academy:
MedDev Central Knowledge Hub:
International Medical Device Regulators Forum (IMDRF):
United States of America (USA):
Food and Drug Administration (FDA) guidance on the status and transition to Quality System (QS) regulation (21 CFR Part 820):
International Standards:
ISO 13485:2016: Medical devices - Quality management systems - Requirements for regulatory purposes
European Union (EU):
Medical Devices Regulation (MDR) 2017/745:
- QMS Requirements: Chapter I, Article 10(9)
- Conformity Assessment based on QMS and TD: ANNEX IX, Chapter 1
In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746
- QMS Requirements: Chapter I, Article 10(8)
United States of America (USA):
Food and Drug Administration (FDA), Federal Food, Drug, and Cosmetic Act (FD&C Act):
Good Manufacturing Practices (GMP): Regulations that require manufacturers to ensure products are consistently produced and controlled according to quality standards.
Intended purpose: The use for which a medical device is intended according to the information provided by the manufacturer on the labelling, in the instructions for use (IFU), or in promotional materials. This may also be referred to as the Intended Use in some jurisdictions. Also see Indication of Use.
ISO 13485: An international standard that specifies requirements for a quality management system (QMS) specific to the medical devices industry.
Manufacturer: A legal entity that designs, produces, assembles, or labels a medical device with the intention of placing it on the market.
Post-Market Surveillance (PMS): The proactive collection and review of experiences and data related to a device after it has been released onto the market to ensure continued safety and performance.
Process Controls: The tools and methods to monitor and manage medical device manufacturing processes.
Process Verification: Uses process controls to check individual manufacturing steps and components against specifications.
Process Validation: Ensures that the entire manufacturing process, supported by process controls, reliably produces products meeting all requirements.
Quality: The degree to which a device consistently meets regulatory requirements and user expectations for safety, efficacy, reliability, and performance.
Quality Assurance (QA): The systematic activities implemented to ensure that devices consistently meet regulatory requirements and standards while meeting user needs and expectations.
Quality Controls: The measures and tests conducted on the final product or at the end of the production process to ensure it meets all specified quality standards and regulatory requirements.
Quality Management System (QMS): A formalised system that documents the structure, responsibilities, and procedures required to achieve effective quality management.
Regulation: The rules, laws, standards, and requirements set by regulatory authorities to ensure the safety, efficacy, and quality of devices intended for medical use.
Regulatory Authority: An official body overseeing and enforcing laws, regulations, and standards within a specific industry or sector to ensure compliance and protect public interests. Also known as a Regulatory Authority. Also see Competent Authority and Notified Body.
Standard: A document that provides guidance, requirements, or specifications established by regulatory bodies, industry organisations, or international consensus groups.
Technical Documentation: All documents that demonstrate the design, manufacture, and performance of the device, essential for ensuring compliance with regulatory requirements. This is also known as the Technical File.