ISO 13485 certification is an industry specific standard. It specifies requirements for quality management system or QMS that can be used by an organization involved in one or more stages of the lifecycle of a medical device. The standard applies to component manufacturers and service organizations, as well as manufacturers of the finished devices.
What are the steps to get ISO 13485 Certification?
Benefits of being ISO 13485 certified:
Helps minimize manufacturing defects safety as a key focus.
Helps growth efficiency, cut costs and monitor performance.
Determines that your company has the ability to produce safe medical devices.
Determines that your company has the ability to produce safe medical devices.
Helps minimize manufacturing defects safety as a key focus.
