Introduction to quality in medical devices
In medical devices, “quality” refers to the degree to which a device meets specified requirements and standards to ensure its safety, efficacy, and reliability.
Key aspects of quality in medical devices include:
- Safety: Ensuring the device does not pose any risk to patients or users when used as intended.
- Efficacy: The device performs its intended function accurately and consistently.
- Durability: The device maintains its performance and safety over its expected lifespan.
- Compliance: Adherence to regulatory standards and guidelines set by authorities.
- Usability: The device is user-friendly, with clear instructions and intuitive operation.
- Manufacturing Standards: Consistent production processes that adhere to good manufacturing practices (GMP).
- Post-Market Surveillance: Ongoing monitoring and quality control to address any issues that arise during the device’s lifecycle.
Overall, quality in medical devices ensures that they provide the intended health benefits without causing harm, thus protecting patient safety and improving clinical outcomes. This is achieved through two interrelated concepts: quality management and quality assurance.
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. Key components include:
- Quality Management System (QMS): A structured system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. Standards like ISO 13485 are specifically designed for medical devices.
- Continuous Improvement: Implementing processes for ongoing product quality and operational efficiency improvement.
- Leadership and Commitment: Management’s involvement in promoting a quality culture within the organisation.
- Risk Management: Identifying and mitigating risks associated with the product lifecycle.
Quality Assurance
Quality Assurance (QA) is a subset of quality management focused on ensuring that quality requirements will be fulfilled. It involves systematic activities and planned actions to ensure products are developed and manufactured according to specified requirements. Key components include:
- Verification and Validation: Activities to confirm that the product meets design specifications and performs as intended.
- Process Monitoring and Control: Ensuring that processes involved in the development and manufacturing of medical devices are consistently followed and controlled.
- Documentation: Maintaining thorough records of processes, tests, and inspections to demonstrate compliance and traceability.
- Compliance Audits: Regular inspections and audits to ensure adherence to regulatory standards and internal procedures.
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.