EDQM certification for Bovine Tissue (ISO 22442)

A publicly listed medical technology company is a leading global provider of innovative devices for the treatment of peripheral vascular disease. Also develop, manufacture, and market disposable and implantable vascular devices to address the needs of vascular surgeons.

The client did not have in-house expertise to prepare the documentation is necessary to submit for EDQM certification.

BridgeMed solutions consultant took over this project, prepared necessary documents such as EDQM dossier and Expert opinion document. This activity resulted EDQM approval in record time of 87 days. Generally it takes at least 4-5 months for EDQM to come back with follow-up questions and another couple of months to resolve the questions and obtain approval.