The compliance dates for the European Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) are quickly approaching. Are you ready?
To support our clients and industry colleagues, Treximo, a global consulting and solutions partner to Medical Device and Diagnostics companies, is pleased to offer a multi-session webinar series covering a range of topics focused on helping manufacturers efficiently transition from the current MDD/IVDD regulatory framework in Europe to MDR/IVDR. Learn more about the specific changes to the Medical Device Regulation requirements in Europe here.
What we'll cover:
In our second training session, Belinda Larson, who was until recently a clinical evaluation specialist at BSI, will discuss how to successfully create a clinical evaluation plan (CEP) under the Medical Device Regulations.
With the CEP acting as the template for a successful clinical evaluation, it is critical to create it with your overall clinical strategy in mind. Belinda will discuss the elements needed to meet the requirements of the MDR, Annex XIV Section 1a, as well as share strategies to help manufacturers navigate the hazardous path on the way to demonstrating clinical safety and performance of their device.
We hope you can join us!
Senior Director, Device and Diagnostics Writing, Treximo
Belinda (Binnie) Larson is a Registered Nurse with 6+ years experience in the clinical setting and 17+ years in Fortune 500 medical device companies. She has worked in the areas of complaint / vigilance reporting, structural heart device consulting, clinical research management, clinical evaluation report composition and project management as the clinical lead for the Medical Device Regulation (MDR) readiness project. Most recently, Binnie worked as a clinical evaluation specialist for a large Notified Body assessing the clinical and risk management documents for compliance to the Medical Device Directive (MDD) and the MDR. Binnie graduated with distinction when she received her master’s degree in the field of Nursing awarded by Walden University. She also holds a certificate in Clinical Research and Design from the University of Southern California (USC).
Ronald Freeze, PhD
Senior Vice President, Device and Diagnostics, Treximo
Ron has over 20 years of experience in the healthcare industry in research and development and regulatory spanning diagnostics, pharmaceutical and biotechnology businesses. Ron was most recently focused on ensuring his team was structured correctly and had the right skills and resources to successfully execute the largest and fastest global launch of a new diagnostics platform and assays in the company’s history. Throughout his career, Ron has concentrated on recruiting and retaining the top talent to consistently exceed the expectations of both internal and external partners. In his current role, Ron leads the functional subject matter expert teams within the quality organization of Treximo focused on the device and diagnostics areas. Ron holds a PhD in Analytical Chemistry from Iowa State University, a BA in Chemistry Education from the University of Northern Iowa and his Regulatory Affairs Certification.
Treximo, part of The Planet Group, is a global consulting and solutions partner to industry-leading Biotech, Pharmaceutical, Medical Device and Diagnostic companies. Headquartered in Chicago, Illinois, quality is at the heart of everything we do. We ensure risk assessment, clinical evaluation, compliance and manufacturing improvement at every turn. Read more about our approach to EU MDR and EU IVDR Implementation here.