Biocompatibility Submissions Webinar: Navigating FDA & MDR
Join us for an insightful webinar this March 26th, where we delve into the intricacies of biocompatibility submissions under both the U.S. Food and Drug Administration (FDA) and the European Union’s Medical Device Regulation (MDR). This session is tailored for professionals seeking to understand the nuanced requirements and streamline their product approval processes in these major markets.
What You’ll Learn:
In this session, you’ll explore the key distinctions between FDA and MDR biocompatibility requirements, understand how medical devices are classified under each regulation, and learn effective strategies to enhance submission success. With insights into meeting MDR requirements efficiently, including guidance on the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) for compliance.
- Key Differences Between FDA and MDR Submissions: Compare biocompatibility requirements across both regulations.
- Medical Device Classification: Learn how FDA and MDR classify medical devices and the impact on submissions.
- Strategies for Successful FDA Submissions: Discover best practices to improve your FDA submission success.
- Strategies for Successful MDR Submissions: Gain insights into meeting MDR requirements efficiently.
- Additional MDR Requirements: Guidance on Clinical Evaluation Plan (CEP) & Clinical Evaluation Report (CER) for MDR compliance.
Why Attend?
Navigating the regulatory landscapes of both the FDA and MDR is essential for medical device manufacturers seeking global market approval. This webinar provides a valuable opportunity to gain expert insights, clarify complex regulatory requirements, and enhance your submission strategies. You’ll also have the chance to engage with our industry expert, ask questions during the live Q&A session, and apply these learnings to streamline your compliance process and accelerate market entry.
Cormica’s mission is to improve patients’ lives by providing comprehensive testing services, enabling clients to launch and release their products safely and rapidly across the world.Â
Biocompatibility testing is a critical step in ensuring the safety and compliance of medical devices before they reach the market. Cormica offer comprehensive ISO 10993 biocompatibility testing services, helping manufacturers meet FDA, MDR, and global regulatory requirements. Our expert team provides tailored testing solutions, from initial risk assessments to full biological evaluations, ensuring your device meets the highest safety standards efficiently and effectively. Partner with us for end-to-end support in navigating regulatory complexities and accelerating product approval.
With Cormica’s experienced team and advanced testing capabilities, you can be confident in meeting industry standards. Whether you’re developing new syringes or optimising existing products, contact us today to discuss your testing needs at sales@cormica.com
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Author:
Elena Henderson
Principal Consultant
Cormica
Elena Henderson is a consultant on Biological evaluations for Medical devices within ISO 18562 and ISO 10993 series. Elena worked for 8 years at Cormica MET as Biocompatibility assessor and contributed to effective submissions to UK, EU and US authorities. Elena is a Member of Royal Society of Biology MRSB P0149152, Member of BSI committee CH/121/9 “Lung Ventilators & Related Equipment” 2022, and a Member of British Toxicological Society 2022 MBTS 1079888.