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Primo Medical Group is compliant with ISO 13485:2016. Download certificates here: ISO 13485 2016

By adopting ISO 13485:2016, we commit to a rational foundation for us to address the European Union (EU) Medical Device Directive, the EU Medical Device Regulation, and other regulations. It also demonstrates Primo Medical Group’s commitment to the safety and quality of our medical devices.

Some of the key additions to the 2016 update include:

  • Greater Emphasis on Risk
  • More Detailed Explanation of Management Responsibilities
  • Addition of Complaint Handling
  • Clarification of Training Responsibilities
  • Increased Emphasis on Control of Suppliers
  • Improvement to the Facility Requirements
  • Better Alignment of Design and Development Requirements to Many Regulations
  • New Obligations for Traceability Procedures
  • Augmented Product Cleanliness Requirements