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.
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).
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 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responsible for the development of clinical procedure and technical guidance for BSI reviewers, and consulted on MDCG draft guidance prior to publication, including IVD batch verification, summary of safety and performance, IVD classification rules, and performance evaluation for SARS-CoV-2.