Welcome to the RA QA Café

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FDA Releases Draft Guidance: Content of Premarket Submissions for Device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