Tuesday, June 5; 11 AM – 12 PM
Speakers: Maureen Mooney, Senior Principal Specialist, Regulatory & Quality Solutions (R&Q)
Caroline Leab, Director of Regulatory Affairs, Abbott
Speaker introduction and moderation: Juli Denny, Vice President of Sales & Marketing, Regulatory & Quality Solutions (R&Q)
What do I need to start the portfolio planning process? MDR document and data organization is critical to creating and implementing an efficient EU MDR portfolio planning process and transition plan. MDR portfolio planning begins with the process of combining technical documents and data with regulatory requirements into a manageable database. The inputs include identification of design dossiers and technical files and the FG part numbers on the corresponding DOC’s, EC certification expiration dates, planned product lifecycle management obsolescence dates, and preliminary assessment of remediation needs as a result of classification changes, lack of clinical evidence, and legacy product issues.All of these inputs are used to realign and reduce regulatory files, schedule remediation and file transition activities, and propose portfolio plan revisions that benefit the company –considering the significant cost and resources needed to transition products to the EU MDR. We’ll provide real-world examples of using this process, share efficiencies gained from it, and demonstrate the effective communication and alignment that can be achieved as a result.