In vitro device manufacturers around the globe are facing regulatory changes if they want to continue to sell their products in the EU. With the compliance date for In Vitro Diagnostic Regulation (IVDR) rapidly approaching, every one of these companies will need to assess their current practice and make adjustments ensuring compliance by May 26, 2022.
Are you ready? Is your team aware of the new product classifications? Do you have a quality management system set up for a smooth transition? Have you reevaluated your supply chain and contractors?
This webinar will provide the tools you need to prepare for this crucial change. MDR and IVDR expert Sundeep Agarwal explains how a company creating in vitro devices will need to move forward with these shifts before the implementation deadline, from software considerations to understanding authorized representatives.
- Key Changes Arising from IVDR
- Details around Certifications and Evaluations
- The Benefits of Quality Management Systems
- Supply Chains and Subcontractors
- Preparing for Audits