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...
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Get the Facts on Microbial Reduction in Food Ingredients
There’s a lot of urban legend when it comes to using gamma radiation to reduce pathogens in...
Get the Facts on Bioburden Control and Sterilization for Food & Beverage Packaging
This eBook, 'Get the Facts on Bioburden Control and Sterilization for Food & Beverage Packaging,' addresses common...
FAQs for Pet Treats Manufacturers: Get the Facts on Pathogen Reduction in Pet and Animal Nutrition
If you’re a manufacturer looking to reduce bacteria in pet treats and animal feed that you sell...
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...