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Are your Risk Management Files (RMF) and labeling outputs ready to withstand rigorous Notified Body and FDA scrutiny? As regulatory expectations tighten under EU MDR, UKCA, and the FDA QMSR, weak traceability between your risk assessments and your IFUs is one of the fastest routes to a major deficiency. ...

Join the 𝐓𝐰𝐢𝐧 𝐂𝐢𝐭𝐢𝐞𝐬 𝐑𝐀𝐏 𝐂𝐡𝐚𝐩𝐭𝐞𝐫 for an In-Person Event! 𝘖𝘯-𝘓𝘢𝘣𝘦𝘭, 𝘌𝘹𝘵𝘳𝘢-𝘓𝘢𝘣𝘦𝘭, 𝘢𝘯𝘥 𝘖𝘧𝘧-𝘓𝘢𝘣𝘦𝘭: 𝘚𝘵𝘳𝘢𝘵𝘦𝘨𝘪𝘻𝘪𝘯𝘨 𝘔𝘦𝘥𝘪𝘤𝘢𝘭 𝘋𝘦𝘷𝘪𝘤𝘦 𝘊𝘰𝘮𝘮𝘶𝘯𝘪𝘤𝘢𝘵𝘪𝘰𝘯𝘴 𝘶𝘯𝘥𝘦𝘳 𝘍𝘋𝘈 𝘙𝘦𝘨𝘶𝘭𝘢𝘵𝘪𝘰𝘯𝘴 𝘢𝘯𝘥 𝘎𝘶𝘪𝘥𝘢𝘯𝘤𝘦 (𝘛𝘩𝘦 𝘔𝘶𝘴𝘪𝘤𝘢𝘭 𝘌𝘥 ...

Hi Nancy, Thanks! So, it was the confirmation email from Raps that says Feb 5? Can you forward me the message? I just registered and did not see the Feb 5 date in the email. Georgiann

The new QMSR rules are here, and they're already reshaping FDA inspections. Let's talk about what FDA investigators are looking for under the harmonized, risk-based framework, and how you can stay ahead of the curve. Join us for a conversation on real-world inspection readiness, from complaint handling ...

Join us for an in-person educational session on the EU AI Act, presented by Jeongpyo (JP) Hong, MS, MPH, Lead Auditor at TÜV SÜD, on Tuesday, November 18, 2025, from 5:00 PM to 7:30 PM Central Time (US & Canada). Learn how this new regulation impacts medical device manufacturers and discover the steps ...

REGISTER TODAY! Both experts and those entering into the regulatory industry will benefit from this event. 3 key reasons to attend this event: 1. Gain a Foundational and Practical Understanding of the Pre-Sub Program: You will learn what the FDA Pre-submission (Pre-Sub) program is, and more importantly, ...