
News & Insights


Predetermined Change Control Plans (PCCP) For AI/ML Software As Medical Devices (SaMD)
SaMD developers often face the challenge of determining whether a new marketing submission is necessary for certain software modifications. In a LinkedIn audio event, several experts from Biologics Consulting’s Medical Device Business Unit will discuss insights on how a PCCP can save you valuable time and resources by eliminating the need for post-market assessments and potential delays in the future. Connect with fellow industry leaders, learn from experts, and gain the knowledge you need to optimize your software modification processes and stay ahead in the ever-changing world of AI/ML SaMD.





Predetermined Change Control Plans (PCCP) for AI/ML Software as Medical Devices (SaMD) – LinkedIn Live Event
Join our medical device experts for a LinkedIn Live event on Wednesday June 21 covering Predetermined Change Control Plans (PCCP) for AI/ML Software as Medical Devices (SaMD).

“Weight of Evidence vs Carcinogenicity Testing (Part 2)” Featuring Bruce Pearce
Pharmacology and toxicology expert, Bruce Pearce, continues sharing his insight about the new FDA S1B guidance R1 addendum. These changes may allow you to forgo carcinogenicity testing in favor of a weight of evidence argument. On this episode of Insight at Biologics, we explore the many factors involved, including the 2 year rat and rasH2 mouse studies, pharmacologic mechanisms, toxicology studies, and more.


“Weight of Evidence vs Carcinogenicity Testing (Part 1)” with Bruce Pearce
The ICH has released a new guidance which may allow you to forgo animal carcinogenicity testing in favor of a weight of the evidence argument. We begin our two-part discussion of why this has been added, including the goals of the addendum, on this episode of Insight at Biologics featuring expert Bruce Pearce. And, tune in next time for part 2 to find out how to go about this.