Upcoming Events

As the life sciences industry continues to evolve, this event serves as a powerful platform to connect, collaborate, and drive forward transformative solutions.

HLTH Europe is Europe’s #1 healthcare innovation, redefining the future of health.

Expert guidance from regulators and industry to streamline compliance, stay deadline-ready, and advance patient safety through rigorous science

Learn how AI governance in life sciences is evolving. ISO/IEC 42001 offers a practical framework for compliant, risk-based AI management—without overhauling your QMS. Discover how to close the gaps and prepare for what's next.

Join us for a networking event at Strangelove’s in the heart of Philadelphia! Meet regulatory professionals and connect with chapter leaders over happy hour bites.

This webcast identifies common pitfalls in parallel EU IVDR and US FDA regulatory planning for IVD devices and illustrates how early design and development

Join RAPS Boston for an in-depth session unpacking the real world regulatory playbook for AI-enabled wearable devices, from first submission to post-market evolution. Learn from industry leaders Robert Michalik and Tahir Rizvi as they reveal how AI fits within design controls, accelerates development, and reshapes clinical strategy. Gain actionable insights on PCCPs, FDA engagement, and risk mitigation to streamline 510(k) clearance. Leave with a stronger understanding of the AI regulatory landscape and practical insights to support informed decision-making.

This webinar will provide practical insights into evolving EU MDR clinical pathways, with real-world examples and key pitfalls from pre-clinical to post-market phases, including emerging routes like orphan and breakthrough devices.

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.

Vorträge und eine Paneldiskussion über die aktuellen regulatorische Anforderungen – von REACH bis CLP – sowie Einblicke in die regulatorische Praxis der AG Stoffregulierung bei SPECTARIS.

This session explores how current regulatory leaders can intentionally shift from being technical experts to becoming talent multipliers within their organizations.

This workshop focuses on integrating the EU AI Act into MDR/IVDR by unifying QMS, documentation, and risk management, while also demonstrating how AI tools can handle regulatory data and automate compliance

In de afgelopen maanden zijn er diverse voorstellen gedaan vanuit de Europese Commissie voor aanpassingen in wet en regelgeving die impact (gaan) hebben op alle stakeholders die met medische hulpmiddelen en in-vitro diagnostica te maken hebben. Tijdens onze 43e sessie gaan we een dag wijden aan een selectie van de onderwerpen. Hierbij komen vertegenwoordigers van de overheden en Notified Bodies aan het woord, en wordt de impact voor fabrikanten en ziekenhuizen bekeken. Daartoe zijn panels en parallel sessies gepland.

Western Canada Chapter Meet & Connect- Seattle

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 workshop will address the gaps, if any, in the current ISO 13485: 2016 QMS standard to avert cybersecurity threats and ensure data integrity.

This webinar will examine the regulatory impact of EU Group Differences introduced in EN IEC 61010 2 101:2022/A11 for in vitro diagnostic (IVD) devices. The session will also address laser and LED radiation safety considerations relevant to modern IVD technologies.

This webcast will explore how labeling has evolved over the past 15 years, highlight key regulatory and operational shifts, and provide forward-looking insights on how emerging technologies are transforming the future of labeling.

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.