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Regulatory intelligence and strategy for medical devices Part 1 – Series introduction

Regulatory intelligence and strategy for medical devices

Today, our conversation brings up difficult but necessary questions to think about THE CURRENT STATE OF PREPARATION of the #aregualtoryaffairs processes to deal with the frequent change imposed by the regulators on the medical devices market.

The constant change creates the need to carry out #regulatoryintelligence activities regarding the themes that affect the #negocio, even though these activities are essentially DIFFERENT from the usual RA.

Yes, it is another SET OF SKILLS, that is, if the information is not optimized for the business, if a lot of time and energy is spent in this process, which is then missing on other fronts, or if important information goes unnoticed, the root of the problem lies in the fact that Regulatory Intelligence is a DIFFERENT ACTIVITY, involving other areas of knowledge. This is not the fault of the “regulatory staff”.


– different operating markets and multiple sources;

– mapping and monitoring over time;

– separate “the chaff and the wheat”;

– communicate all this in the right way in a timely manner;

And ready, we have the recipe for difficulties that you may be experiencing in your day to day.

# regulation # warning # health #medicalbusiness

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