How many of you have initiated contact with someone you haven’t met (in person) as you struggled to answer a challenging internal query? During this period of lockdown and working from home, I have found myself reaching for my contact lists, both internal and external, more often than in previous months.
Regulatory change strategy may be defined as “the comprehensive elucidation of a project designed to achieve a specific regulatory goal, such as to obtain a new approval or clearance of an amendment.”
Can you identify your critical suppliers, link each to their respective product codes and registration status? Many medical device regulatory affairs teams struggle to connect these dots.
The EUDAMED database and related compliance activities may be implemented earlier than previously expected. Now is the time for regulatory operations teams to engage with their cross-functional colleagues to determine when and how they will implement the regulatory data requirements within their business.