Internal Audit Be Ready for FDA Inspections Hope is not a Strategy
Life science companies recognize that the FDA inspection process is a cornerstone of ensuring the safety and...
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IVDR Regulation for Medical Device Directive in EU: Impact Assessment of Revision of the Regulatory Framework for MDD in EU
The existing regulatory framework for medical devices, which has been in place for 20 years, has recently...
US Food and Drug Administration Regulatory Pathways
Over the past five years, the medical device industry has witnessed an explosion of new and innovative...
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...
Artificial Intelligence and Machine Learning Based Software as a Medical Device
In our first episode, host Erika Porcelli is joined by Lisa Michels, General Counsel and Regulatory Affairs...
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...
Merger and Acquisition Re Registration: Navigating the Re Registration and other Complexities of M and A and Carve Outs
In M&A or carve-outs, pharmaceutical executives often underestimate the complexities of disentangling operations and the extensive effort...
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...