When Biocompatibility and Clinical Evidence Fall Out of Sync, Your Device Submission is At Risk
For high-risk implantable and interventional devices, biocompatibility evaluation and clinical evidence generation usually run on parallel tracks. Each moves forward on its own timeline, and they rarely reconcile until a submission. By then, chemical characterization findings, biological assessments, and clinical protocols have often drifted apart. When that happens, submissions reach the FDA or a notified body riddled with unanticipated gaps, and the program must absorb late-stage delays and expensive rework to close them.
RQM+ was built to prevent this kind of problem. As a MedTech-specific CRO specializing in complex devices, RQM+ pairs clinical and regulatory strategists who have worked the FDA and notified-body side of the table with the analytical strength of Jordi Labs, an in-house, FDA-recognized laboratory whose proprietary Lumo™ platform enhances extractables and leachables (E&L) and biocompatibility characterization.
In this session, Jordi Labs biocompatibility lead Kaitlin Lerner and Deborah Morley, Ph.D, Director Cardiovascular Center of Excellence (CV CoE) & CV Strategy and Delivery, draw from real implantable and interventional device work to show how sequencing biocompatibility and clinical activities together from the earliest program stages keeps high-risk programs moving forward.
What You’ll Learn
- How to coordinate chemical characterization, biological evaluation, and clinical evidence activities with current FDA and EU MDR expectations
- Which biocompatibility and clinical activities a lean MedTech team should keep in-house, and which to route through external expertise
- How to anticipate the pitfalls that often stall high-risk device submissions
Who Should Watch
Regulatory affairs and clinical affairs leaders, biocompatibility and toxicology specialists, quality and R&D program leads, and anyone accountable for evidence and regulatory strategy at companies developing high-risk implantable or interventional devices.
Speakers
- Kaitlin Lerner, M.S. — Vice President, Biocompatibility and Scientific Excellence, Jordi Labs, an RQM+ Company
Kaitlin has more than 15 years in regulated laboratory environments, where she leads biocompatibility, E&L, and analytical testing strategy for medical devices and combination products. She has advised global MedTech manufacturers, shaped testing strategy for high-risk devices, and helped integrate machine learning into chemical characterization. She holds an M.S. in Analytical Chemistry from the Illinois Institute of Technology. - Deborah Morley, Ph.D. — Director, Cardiovascular Center of Excellence (CV CoE) & CV Strategy and Delivery, RQM+
Deborah has spent more than 30 years leading global regulatory, clinical, and quality programs for Class III implantable and circulatory support technologies, from early feasibility through global market approval. She has secured FDA PMA approvals, Breakthrough Device Designations, IDE approvals, and CE Mark certifications across cardiovascular technologies spanning heart failure therapies, cardiac contractility modulation systems, ventricular assist devices (LVADs), and structural heart technologies. As a published author and former academic researcher in cardiovascular physiology, she brings a proven record of guiding FDA, notified body, and competent authority interactions.
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