Upcoming Events

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.

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

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.

Designed for senior regulatory leaders, this program sharpens high-level communication, strategic decision-making, and risk management skills. It equips participants with proven techniques to align stakeholders, foster inclusion, and navigate complex, high-stakes environments with clarity and confidence.

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.

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