Why ISO 13485 Certification Matters in Product Development

Bold Type achieved ISO 13485 certification this year. And if you’re a medical device company looking for a product development partner, that certification can mean the difference between a successful 510K submission and a rejected one.

As I explained to Paul Enderle of BayCross Capital,  ISO 13485 certification means that we have a full quality management system in place, compliant with both FDA and CE mark requirements.

It means that we’re documenting our design inputs, outputs, design verification and validation testing in accordance with the requirements, and that we’re storing and maintaining those documents appropriately.

This greatly reduces risk for manufacturers, especially when the FDA auditors come around and find the design history file and all other associated documentation is just as it should be.