ISO 13485 Medical Devices: Quality Management Systems
What is ISO 13485?
Put simply, ISO 13485 is the QMS standard for the medical device industry. Based on the ISO 9000:2008 series, ISO 13485 uses a process-based approach to ensure the quality of the medical device design, manufacturing, installation and service, and is applicable for all stages of the product life cycle.
It supports medical device manufacturers by demonstrating compliance with regulatory requirements in the following areas:
- Management responsibility
- Resource management
- Product realization
- Measurement, analysis and improvement
ISO 13485 is also at the core of the Medical Device Single Audit Program (MDSAP).
What is MDSAP?
The Medical Device Single Audit Program allows an MDSAP recognized auditing organization, such as SGS, to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program, including:
- Therapeutic Goods Administration of Australia (TGA)
- Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
- Health Canada
- Japan’s Ministry of Health, Labour and Welfare, and the Japanese
- Pharmaceuticals and Medical Devices Agency (PMDA)
- U.S. Food and Drug Administration (FDA)
Health Canada requires medical device manufacturers to be certified to MDSAP in order to legally market any class II, III or IV device in Canada. The other participating jurisdictions use the report as a means to support marketing authorization decisions and maintain effective oversight of medical device manufacturers that market devices within their countries. Additionally, MDSAP visits replace regular FDA quality system regulation (QSR) inspections.
MDSAP is a transparent, predictable approach for companies who wish to reduce regulatory distraction, and maintain a program for international conformity assessments with predictable occurrence and duration.
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ISO 13485 is the quality management system (QMS) standard that provides the framework by which manufacturers of medical devices can demonstrate their ability to consistently meet customer and regulatory requirements, as well as their commitment to quality and patient safety.
Transform your medical device quality management system with ISO 13485
