Learn the key steps to ensure compliance, avoid common pitfalls, and successfully navigate the transition process
As of April 2022:
90% of currently valid AIMD/MDD certificates were set to expire in 2023.
50% of resubmitted applications were deemed incomplete.
30 notified bodies are designated under MDR, managing 80% of current AIMD/MDD certificates.
Despite the extension recently approved by the European Commission, the transition to the EU MDR is a complex and ongoing process that requires careful attention to detail and a commitment to ongoing compliance. Manufacturers should work closely with notified bodies and other regulatory experts to ensure that they understand the new requirements and have a plan in place to meet them. Failure to comply with the EU MDR can result in an inability to market devices in the European Union.
Learn the key steps to ensure compliance with the new EU MDR regulations, avoid common pitfalls, and successfully navigate the transition process from industry leaders Thomas Moore, PhD and Sam Mostafavi, MSc, MBA from PTL Solutions.
- Background on MDD/IVDD to MDR/IVDR transition.
- Differences between old and new regulations.
Step-by-step strategies for transitioning to the new regulations.
- Valuation process and timelines for acquisitions
The role of advisors.
- Hear real-world examples of how others have managed this transition.
Thomas Moore, PhD
Independent Consultant – Medical Device Development
Thomas has worked in the Medical Device Industry for almost 20 years and has extensive experience leading projects that are compliant with FDA, EU, and ISO regulations. Throughout his career as a medical device development professional, Thomas has honed his skills at developing and refining quality processes to be compliant, efficient, and properly created to ensure staff understands them and comply with them day to day. Thomas has significant experience assessing and improving Quality Management Systems (QMS) and accompanying documentation, both from a Quality perspective and from a Production perspective. Thomas has a B.S. in Aerospace Engineering, a MASc in Mechanical Engineering, and a dual Ph.D. in Mechanical and Biomedical Engineering
Sam Mostafavi, MSc, MBA
Sam has over 20 years of drug, biotech, and medical device industry expertise. He has extensive experience in product and software development lifecycle from concept to commercialization, including design development, regulatory strategy, authoring of regulatory submissions, study planning, quality system, manufacturing, and post market surveillance. Sam also has experience in international regulatory approval and production facility setup and qualification. This includes extensive experience supporting MDD to MDR transition projects for several medical device manufacturers and products. Sam served as the U.S. Agent Representative for several international manufacturers and attends FDA-Sponsor meetings as needed. He is familiar with FDA regulations and guidance, as well as policies and procedures at CDRH. Sam has received B.S. in Electrical Engineering, Master of Science in Computer, as well as MBA from Old Dominion University.