“ISO 13485 Certified” means an organization has implemented an ISO 13485 Quality Management System and has successfully met all of the requirements in ISO 13485. ISO 13485 evaluates whether your Quality Management System is appropriate and effective while emphasizing the safety and efficacy of medical devices.
ISO 13485 Certification incorporates 8-clauses, three of which give direction on the expected utilization of the standard. The staying five provisos give the system to what is required of associations committed to clinical gadget creation. In this way, this is what to expect so as to accomplish consistence.
6 steps to ISO 13485:2016 certification
Planning the quality system.
Meeting regulatory requirements. While developing your quality plan, U.S. medical device companies must comply with FDA 21 CFR 820.
Implementing design controls.
Documents, records, and training.
Management processes.
The Certification audit.
Benefits of ISO 13485 Certification
Expansion in national and international market Access (Increase device sales by accessing more national and international markets.)
Meet and regularly monitor Regulatory Requirements
Gain a competitive edge
Reduced cost of sales
Improved performance
Integrated Services :
ISO 13485 can be integrated with ISO 9001
ISO 13485 can be integrated with ISO 14001
ISO 13485 can be integrated with ISO 45001
ISO 13485 can be integrated with ISO 27001
ISO 13485 can be integrated with CE Compliance and certification