Aging Facilities and In-Shoring Product to the US
In this episode, host Erika Porcelli is joined by Brendan McCrea, Regulatory Compliance Associates (RCA) Director of...
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US Food and Drug Administration Regulatory Pathways
Over the past five years, the medical device industry has witnessed an explosion of new and innovative...
Challenges in Design Development – Why Design Control Makes Sense
The journey from a novel idea for a new medical product to its commercial realization involves significant...
Sterilization Dose Audits – The “Why” and the “How”
In the medical device industry, sterilization processing is performed to obtain a Sterility Assurance Level (SAL) as...
Outsourcing Surveillance Activities
In this episode, host Erika Porcelli is joined by Steve Cox, a Senior Consultant at Regulatory Compliance...
Data Integrity and Quality Culture
In this episode, host Erika Porcelli is joined by Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates...
Clinical Evaluation Requirements for Medical Device – Meeting Medical Device Clinical Evidence Requirements – CE Marking
Clinical Evaluations are mandated by the Medical Device Directive (MDD) to ensure the safety and efficacy of...
Navigating Complexities of Name Changes and Re Registrations
Medical device manufacturers often overlook the complexities involved in changing product names or ownership, both of which...
Pharma Product Launch and Lessons Leaned Crisis Playbook: Lessons learned from Real Investigations of Product Failures
When a medical or pharmaceutical product fails in the field, the repercussions are far-reaching. Not only do...