Past Events

Join the NJ and Philadelphia chapters as we host FDA and Intertek speakers discussing FDA’s Accreditation Scheme for Conformity Assessment (ASCA) and how it streamlines premarket review by elevating the quality and consistency of testing laboratories, enabling reviewers to assess complex areas like biocompatibility and EMC in minutes rather than hours. This session explains how ASCA reduces deficiencies, protects test data integrity, and demonstrates through real case studies how submissions once stalled for months can move forward in weeks.

Preparing a successful 510(k) requires more than completing a template—it requires a clear regulatory strategy, thoughtful planning, cross-functional coordination, and a thorough understanding of FDA expectations. Join regulatory consultant Nancy Sauer for a practical discussion of 510(k) submission best practices, common pitfalls, and lessons learned from working with FDA's eSTAR submission platform.

This is a RAPS-SF Executives event exclusive for VP and above. This facilitated roundtable provides an intimate, interactive environment for senior professionals to unpack monumental changes at the FDA, share strategic playbooks, and candidly discuss what the "new normal" at the FDA means for our industry.

Join a RAPS San Francisco networking and recruitment series across multiple in-person events. Meet regulatory professionals, connect with chapter leaders, and learn about ambassador and leadership roles. Build your network and support the local regulatory community.

Join SGS and the RAPS Boston Chapter for a high-impact, one-day symposium dedicated to the critical risks and regulatory challenges facing pharmaceutical and medical device supply chains in 2026 and beyond. The program features insightful presentations, expert panel discussions, and practical takeaways designed for regulatory affairs, quality, compliance, and supply chain professionals. The agenda highlights include morning and afternoon sessions, networking lunch, and a closing reception/happy hour from 4:20 – 6:00 PM. Hosted by Scott Blood and Shona D’Souza (RAPS Boston Chapter), this is a must-attend event for professionals seeking actionable strategies to strengthen supply chain resilience and ensure compliance in a complex regulatory landscape.

The RAPS NC Local Networking Group presents an in-person FDA ASCA Program session focused on the appropriate use of standards, conformity assessment, and practical strategies for premarket submissions. Presented by RAPS in partnership with and sponsored by UL Solutions, the event will feature FDA speakers and provide regulatory, quality, testing, and product development professionals with practical insights into how ASCA works and how it can support more predictable device submissions.

A deep dive into European Medical Device Regulation (MDR)

AI hallucinations are the central unsolved problem for deploying language models in regulated industries: medical devices, clinical decision support, and drug development. This session presents the hypothesis that standard LLMs hallucinate because of an architectural gap. They hold no internal state they must remain consistent with, so output is statistical pattern matching rather than a constrained read against a model of self, history, or relationship. The session walks through an architecturally-governed AI substrate whose hormone state, scar memory, and trust lattice function as inspectable reasoning artifacts, and examines the regulatory implications for ALCOA+ audit trails, Predetermined Change Control Plans, and the FDA De Novo pathway for Class II AI-enabled Software as a Medical Device. It closes by opening a broader question this room is uniquely positioned to answer: what kind of validation should AI require before we trust it with regulated decisions?

Is the zero-experience RAPS FRA credential right for you? It's the ideal way for early-career or transitioning professionals to prove foundational RA knowledge to employers and to jump-start their careers.

The ASCA Program allows medical device manufacturers to use Summary Test Reports from accredited laboratories to demonstrate conformity with FDA-recognized consensus standards. It enhances confidence in testing quality and streamlines premarket review.

The Accreditation Scheme for Conformity Assessment (ASCA) Program enables manufacturers of FDA-regulated medical devices to leverage ASCA Summary Test Reports from ASCA-accredited testing laboratories in demonstrating conformity with FDA-recognized consensus standards. The Program enhances confidence in qualified testing laboratories, mitigates risk, and streamlines premarket review of test reports.