Joseph-Richardson Larbi has 18 years of experience in Medical Device (MD & IVD) Regulatory and Quality strategies (from design development to market launch and post marketing activities – compliant to MDD/MDR/IVDR/ISO 13485/9001 Quality Management Systems).
He is experienced in MD CE certification, ISO 14971 Risk Management, Manufacturing and Supplier Management, Manufacturing Verification and Validation, Post Market Surveillance, Clinical Evaluation Reports, Drug Device Combinations, regulatory relationship management, and advance knowledge of FDA Drugs, Biologics, and Biosimilars (IND, NDA, BLA).
Upon conclusion of the program, you will be able to:
- Comprehend the impact of Article 117 of the MDR on Drug Device Combination (DDC) products.
- Understand the current situation and the greatest obstacles from the perspective of EU regulators and medical device
- Gain an understanding of the General Safety and Performance Requirements (GSPRs) which are to be met for combination products prior to placing them on the market.
- Prepare your RA team for Notified Body Opinions under article 117 to ensure a seamless transition and remove any risk of future non-compliance.
This webinar would support those working for companies in the life sciences, including manufacturers of medical devices, with a special emphasis on:
- Regulatory Affairs Managers
- Quality Assurance Managers
- Packaging Development Product and Project Managers
- Technical Writers and Managers
- Operations and Design Managers
- Clinical Managers
- Authorized representatives in Europe