ISO 13485 – Quality Management System certification for Medical Devices

ISO 13485 is not globally mandatory, but it is strongly recommended and often required by regulators or clients in the medical device industry.
In certain jurisdictions—such as the European Union (EU) under the Medical Device Regulation (MDR) and Canada under MDSAP—ISO 13485 certification is harmonized and a well accepted standard as basis for your quality management system.

While ISO 9001 focuses on general quality management principles, ISO 13485 includes specific requirements for medical device safety, risk management, sterile production, and regulatory compliance.
Most regulatory bodies do not accept ISO 9001 alone for medical device certification or market access. ISO 13485 is aligned with healthcare-specific regulations.

Obtaining ISO 13485 certification can offer numerous benefits, including:

• Demonstrating compliance with international regulatory requirements (EU MDR/IVDR, FDA, Health Canada, etc.)
• Gaining access to global markets that require or prefer certified suppliers
• Enhancing product and process quality, patient safety, and traceability
• Increasing customer confidence and improving your reputation in the healthcare sector
• Meeting supply chain requirements