Information for today’s Regulatory Professional
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Today I attended a very informative webinar hosted by British Standards Institute (BSI) on their interpretation of the medical device regulation requirements under Article 117 for drug device combination products marketing in the European Union from 26 May 2021. My objective for attendance was to confirm my understanding of the Article and obtain an interpretation […]
An optimally engineered and collaborative regulatory operations workplace is not a nice to have, but essential for organisational survival and success.
Let’s say I am a medical device importer or distributor and have just begun to think about how to incorporate MDR Article 14 and applicable EUDAMED requirements into my day to day processes, when the regulatory manager at manufacturing company AXV asks me about compliance to MDR Article 16 “Cases in which obligations of manufacturers apply to importers, distributors or other persons”.
Do you currently support your lead revenue generating, life-enhancing product with a collection of bench studies from 20 years ago? Can you effectively follow the history of the product data from when it was called project Heart to Heart3, then on to Tech4567 and finally PaceMaker Elite Mach 76A with titanium? We all know that […]
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.”