Medical Devices Quality Management

ISO 13485:2016 Medical Devices Quality Management System

ISO 13485:2016 is the internationally recognised standard that specifies requirements for a quality management system (QMS) specific to organisations involved in the design, development, production, installation and servicing of medical devices. It is applicable to organisations at any point in the medical device supply chain.

The standard is harmonised with regulatory requirements in key markets including the EU Medical Device Regulation (MDR), the US FDA Quality System Regulation, Health Canada, and the UAE Ministry of Health and Prevention (MoHAP) medical device regulations. Certification is widely required as a prerequisite for market access and regulatory approval.

ISO 13485 shares structural elements with ISO 9001 but includes additional requirements specific to the medical device industry, particularly in areas of risk management, traceability, sterile product controls, and post-market surveillance.

Why take ISO 13485 Certification?

• Required for regulatory approval and market access in EU, US, Canada and UAE
• Demonstrates commitment to patient safety and product quality
• Satisfies prequalification requirements for hospital and healthcare procurement
• Provides a robust framework for medical device risk management
• Supports compliance with EU MDR, FDA QSR and MoHAP device regulations
• Reduces the risk of product recalls, adverse events and regulatory action
• Improves traceability and control across the medical device supply chain
• Builds confidence with healthcare providers, distributors and regulators
• Facilitates entry into international medical device markets
• Demonstrates due diligence and corporate responsibility in healthcare