ISO 13485:2016 Certified
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
Trust the Quality Experts at Primo Medical Group for ISO-Certified Manufacturing and Compliance
Primo Medical Group’s ISO 13485:2016 certification reflects our commitment to the highest standards of medical device quality, safety, and traceability. Our FDA-compliant processes and regulatory expertise ensure that every component and assembly we produce aligns with global requirements for performance and patient safety. Contact us to learn more about our quality assurance systems or request a quote to discuss your next project.