Access the On-Demand Recording

On Tuesday, 17 May at 11 a.m. ET, RQM+ subject matter experts hosted a RAPS webcast, “EU IVDR: Intriguing Insights, Recommended Actions, and a Look Towards the Future.” Fill out the form to get access to the on-demand recording now.

In this webcast, we cover important IVDR topics such as:

• Lessons learned about increased post-market surveillance requirements, QMS audits, technical documentation assessments, and more
• The new IVDR timeline and what it means for manufacturers
• Challenges related to the intended purpose statement
• Clinical evidence requirements for both legacy and new IVDs 
• Key regulatory hurdles around special types of products, including companion diagnostics, near-patient tests, in-house developed tests, Class D devices, and SARS-CoV-2 IVDs

You can expect to learn:

• The impact of the new IVDR timeline on your product portfolio so you can plan accordingly
• Potential notified body feedback in several areas, including intended purpose, clinical evidence, and post-market surveillance requirements
• Expectations and the increased scrutiny mechanism for special types of products
• How to prepare for the future of the IVDR and adapt your transition strategy accordingly

Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s).

Meet the RQM+ Experts:

Kristen Meany MS, CQA, RAC
Principal Advisor

Kristen Meany is a Principal Advisor at RQM+ with nearly 20 years of experience in regulated industry-leading global regulatory teams. She is a strategic and tactical regulatory leader with experience developing regulatory strategies and authoring regulatory submissions for new product development and post-launch changes, including pre-submissions (Q-Subs), 510(k)s, PMAs, technical files and design dossiers (EU MDD), and technical documentation (EU MDR, EU IVDR) for medical devices and IVDs. Kristen has diverse product knowledge coupled with regulatory affairs expertise in medical devices, IVDs, human tissues, pharmaceuticals, and combination products in the fields of orthopedics, neurological and physical medicine, general and plastic/reconstructive surgery, cardiovascular, dental, and microbiology. She has successfully negotiated with regulatory agencies during the development and review of submissions, including leading meetings with the United States Food and Drug Administration, EU Notified Bodies, EMA, TGA, and Health Canada.

Carlos Galamba, BSc, MSc
VP, Intelligence & Innovation - IVD

Carlos Galamba joined RQM+ in Sept. 2021 after seven years at BSI, where he was responsible for managing, coaching, and developing a global team of IVD technical experts in his role as a technical team manager. Among many of his achievements, he was BSI’s first in-house clinician for IVDs, where he led the implementation of the BSI clinical oversight process and has made hundreds of CE marking recommendations for IVDs. At BSI, he supported and led IVDR notified body designations, was responsible for the development of clinical procedure and technical guidance for BSI reviewers, and consulted on MDCG draft guidance prior to publication, including IVD batch verification, summary of safety and performance, IVD classification rules, and performance evaluation for SARS-CoV-2.