Safety and quality are non-negotiables in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery.
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
In addition, the ISO 13485 standard requires that the organization identifies its role(s) in connection with the regulatory requirements (e.g. Manufacturer, Representative, Importer and / or Distributor), and determines the applicable regulatory requirements depending on the role(s), then integrates the regulatory requirements in the QMS.
Benefits of ISO 13485
- Sound and Complete Product Requirements.
- A Defined Process for Effective Risk Analysis.
- A User-Cantered Approach to Product Development.
- The Product Development Process Is Subject to External Quality Reviews.