What is an ISO 13485 Quality Management System?
ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system. ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
What are the benefits?
ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry. ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives. Increasingly, ISO 13485 is being required, or is at least beneficial, in supporting regulations around the world
Although ISO 13485 certification is not a direct requirement for CE marking medical devices under the European Medical Device Directives, it is recognized as a harmonized standard by the European Commission.
In fact, this is the first step in the process of CE-marking our Web Viewer Pro.
Want to know more?
Since we're an open source company, we're happy to chat with you on our experience with achieving ISO 13485 compliance.
A man for whom 24 hours in the day would just be enough, if he could go without sleep. He has a seemingly endless stream of ideas and prides himself on always being on top of everything going on in his company. Frederic used to work as a boring banking consultant until divine inspiration sentenced him to a life of penal servitude to the medical imaging business. But that was just after he learnt the dirty tricks of full stack coding during an excellent 2-month bootcamp.