ISO 13485 certification is no stranger to the medical device world. In this article, we delve into the benefits associated with obtaining this certification. Achieving an ISO 13485 certification represents a significant achievement for medical device manufacturers, as it sets forth stringent criteria for quality management systems to ensure the safety, effectiveness, and reliability of medical devices. Specifically tailored for manufacturers in the medical device sector, the ISO 13485 standard surpasses all previous standards.
In Asia, countries that recognize this standard include Australia, Japan, Malaysia, and Singapore. While India recommends for companies to adopt a standard as close as possible to ISO13485. Outside of Asia, ISO 13485 is required by all European Union members, USA, UK, Canada, and Saudi Arabia.
From the above, I want to highlight ISO 13485's global recognition as a primary standard in quality assurance systems for medical device manufacturers. With certain markets undergoing continuous updates, ISO 13485 continues to serve as its foundation.
Sources:
https://advisera.com/13485academy/blog/2021/03/09/list-of-worldwide-regulations-that-require-implementation-of-iso-13485/
https://apacmed.org/medical-device-regulation/
https://factocert.com/iso-13485-certification-in-india-for-medical-device/
