The predictions of an apocalyptic melt down of the medical device industry has not (yet) come to fruition
Tag archives: #regulatory
Legacy Device Challenges
To date, no horsemen of the apocalypse or world annihilating meteor strike has befallen the medical device industry. However, the continued management of MDD legacy device data is an altogether different cataclysm.
MDR: New Beginning
The act of maintaining MDR compliance now represents one of the biggest challenges for Medical Device companies entering or continuing business in the European market.
Collaboration
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.
Internal Intelligence Supports Change Strategy
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?
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.
And now…EUDAMEDgate
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.