In this first BiocompCHATibility Podcast episode of 2023, our hosts are happy to introducea new podcast to the NAMSA family, and talk a little bit to the hosts about the insightfultopics to come.This new, conversational podcast will feature a new set of hosts who dedicate eachepisode to trending regulatory and quality affairs topics within the MedTech industry.Future topics include:Refuse to Accept Policy for 510(k)s – This episode will delve into the proceduresand criteria FDA intends to use in assessing whether a premarket notification(510(k)) submission meets a minimum threshold of acceptability and if it shouldbe accepted for substantive review.FDA Releases Draft Guidance: Content of Premarket Submissions for DeviceSoftware Functions – As a follow-up to one of NAMSA’s recent blog posts, ourhosts will describe information that the FDA deems important during itsevaluation of the safety and effectiveness of device software with one or moredevice functions.Compliance Pitfalls (Start-up Focus) – This episode will focus on commoncompliance obstacles faced when dealing with documenting procedures,complaint handling processes, supplier controls, audit & training, laboratorycontrols, monitoring and calibration and more.

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