ISO 13485 is an International Standard for Quality Management System (QMS) for medical devices. ISO 13485:2016 compliance is crucial to gain access to global medical device markets, especially in Europe. All medical device manufacturers in Europe must comply with the ISO 13485 standard to obtain CE marking to market their devices. Lately, the US FDA has also proposed to amend its QMS requirements defined under Quality System Regulations (QSR) to harmonize with ISO 13485:2016 compliance standards (Quality Management System Regulation (QMSR)). Organizations complying with ISO 13485 quality management system requirements have the advantage of accessing other markets as well, since Indian Medical Device Rules (IMDR) 2017, Korea Good Manufacturing Practice (KGMP), Brazilian Good Manufacturing Practices (BGMP), and Quality System Documentation (QSD) are similar to ISO 13485 quality management system requirements.
The current version of ISO 13485 compliance came into effect in March 2016. The ISO 13485 quality management system standard requires medical device manufacturers to fulfil its requirements at every stage of the device life cycle. The key requirements for ISO 13485:2016 compliance are enlisted below:
Compliance with the current version of ISO 13485 quality management system requirements is confirmed through audits performed by a Certification Body (CB) or Registrar. On passing the audit the organisation is certified for ISO 13485 which is valid for 3 years. Being ISO 13485 certified implies that the organization has fulfilled all QMS requirements, and the product/s is/are safe and effective to be marketed. The organization must be re-certified every 03 years to maintain the ISO 13485:2016 compliance certification status.
Freyr’s Regulatory experts will guide you meticulously in every step of the device life cycle to ensure seamless implementation ISO 13485 quality management system requirements