Upcoming Events

A moderator’s script is central to human factors validation. It operationalizes the protocol, ensures consistent execution, data collection, and FDA compliance. This webcast shares a proven approach refined through FDA reviews.

A focused overview of EU Commission proposals to evolve MDR/IVDR after 10 years, covering simplification, innovation, Notified Body changes, and future regulatory expectations.

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.

This interactive workshop provides practical, Notified Body–focused perspectives on how manufacturers can build, maintain, and assess EU MDR/UKCA-compliant risk management documentation and related IFU/labeling outputs under ISO 14971 and FDA QMSR.

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.

Please join us for this informal event meant to connect our chapter members to each other and build our professional networks.

A summer to remember, a community to keep

Join RAPS Pittsburgh LNG and Nucleate Pittsburgh for a free happy hour at Local Remedy Brewing. Connect with biotech innovators, students, entrepreneurs, and regulatory experts.

What does AI actually look like in practice when it meets the complexity of medical product development? Who is holding the wheel and where is it all headed? In this rapid-fire session, 7 speakers bring 7 real-world stories in 60 minutes - honest, on-the-ground experiences straight from the people living it. Where does AI deliver? What are its limits? And how are teams navigating the intersection of automation and regulatory expectation? These are questions shaping the industry right now. Attendees will leave with a sharper picture of where AI in regulatory is heading, and concrete examples of tools making a real difference. Join and boost your confidence in the AI arena!

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.

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.

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.

AI hallucinations are the central unsolved problem for deploying language models in regulated industries: medical devices, clinical decision support, drug discovery, and post-market surveillance. 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. This session walks through brain-aligned language models that mirror neurochemistry, with a live demonstration of an AI system whose hormone state, scar memory, and trust lattice are queryable in real time, plus regulatory implications for ALCOA+ audit trails, Predetermined Change Control Plans, and Class II 510(k) submissions.

A deep dive into European Medical Device Regulation (MDR)

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.

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.

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.

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.

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.

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.

This RAPS education webinar is designed to support students and early-career professionals seeking to better understand career opportunities within regulatory affairs and adjacent fields.

Join RAPS Ontario for our Summer Social, featuring an exciting Speed Networking session and inspiring career conversations. Connect with fellow Regulatory Affairs professionals, students, and industry leaders. Hear diverse career stories, expand your network, and enjoy light snacks and refreshments in a relaxed and welcoming environment.

A practical session on biological evaluation of medical devices: ISO 10993, US FDA & EU MDR expectations, and chemical characterization. Hosted by TUV SUD with Medtronic.