Medical Device Quality Management
ISO13485:2016
23 April 2014
What is ISO13485:2016?
ISO 13485 is an international standard that defines the requirements for a Quality Management System (QMS) specifically designed for organizations involved in the design, production, installation, and servicing of medical devices. Its primary purpose is to ensure that medical devices are safe, effective, and consistently meet regulatory and customer requirements. Unlike the more general ISO 9001, ISO 13485 places a stronger emphasis on risk management, regulatory compliance, and maintaining (rather than continually improving) the quality system. It applies across the entire lifecycle of a medical device, from design and development to post‑market servicing. In practice, ISO 13485 is widely recognized by global regulators and is often required for companies seeking to place medical devices on international markets
The standard focuses on how your organisation;
- Controls important documentation and records,
- Manages the competency of employees & resources,
- Manages quality and risk within your production or service provision process,
- Manages critical suppliers and customer requirements,
- Reviews internal processes and problems.
Organisations that we have helped comply with this standard;
- Quoris 3D
