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...
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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...
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...
Implementing Risk Managed Supplier Quality
A risk-managed approach to the global supply chain is more important than ever for life science manufacturers....
Developing a Quality System on a Budget
Developing a robust quality system is fundamental to ensuring that an organization’s products or services are safe,...
GMPs for Early Stage Development Projects
Good Manufacturing Practices (GMPs) should be implemented during the later stages of clinical development, where the final...
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...