Upcoming Events

Whether you are new to medical devices or looking to strengthen your expertise, this intensive 16-hour course, delivered across four half days, has everything you need to confidently implement ISO 14971.

A focused exploration of ISO 10993-1:2025 revision that equips teams to align documentation and manage rising from 2018 revision when remain globally compliant with FDA guidance.

In this workshop, you will learn to align regulatory writing and operations for faster, high-quality global submissions. Discover how early collaboration, shared standards, and smart planning reduce rework, risks, and delays.

Get a preview of this year’s RAPS Convergence, hosted by a special panel of peers who have the behind-the-scenes details to get you ready — and excited — for Charlotte.

This workshop is designed to help regulatory and product development teams successfully bring AI/ML-enabled medical devices to market. You will learn global reg. perspectives from the US FDA, EU MDR and China NMPA.

Learn practical applications and implementation strategies for AI tools in your everyday regulatory affairs and compliance needs

QA/RA teams are under pressure to use AI, but validating non-deterministic tools is unclear. This session provides a risk-based framework to define scope, generate audit-ready evidence, and maintain compliance w/o delay.

The submission process for Master Notified Body Opinions concerning drug-device combinations as required by EU MDR 2017/745.

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.

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

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.

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.

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.

Join this free webcast to find out whether RAC credential is right for you and how to get started. Discover how earning this globally recognized certification can boost your earning potential and your regulatory career.

In this webcast, you will learn how to secure your role as an EU compliance professional. Discover the essential steps to earning the RAPS Regulatory Compliance Certification.

This intensive 16-hour course, delivered across 4 half days, will give you an excellent grounding in the EU requirements for clinical evaluation.

This interactive course gives clinical affairs, regulatory and quality professionals a focused overview of EU IVDR 2017/746 performance study requirements for IVDs and companion diagnostics, with an emphasis on pharma/biotech teams moving into diagnostics or partnering with IVD manufacturers. You’ll explore performance study design and conduct, QMS alignment with ISO13485 and IVDR, bridging analytical to clinical performance, vendor and diagnostic endpoint selection, and dual EU regulatory pathways, and leave with a practical framework for performance study plans to work with CROs or diagnostic sponsors that satisfy both notified bodies.

Gain confidence in implementing the EU MDR! Receive useful advice on updating your quality system, overseeing economic operators, addressing labeling, and handling technical documentation.

Learn how the successful development of combination products will require great collaboration within the industry to overcome regulatory, clinical, and technical challenges.