You are a manufacturer of medical devices or in vitro diagnostics ?
You want to market innovative products ?
You are encountering difficulties in meeting regulatory requirements and standards ? You support innovation and seek expertise in the medical device or in vitro diagnostics field ?
- ANSM : New version of the list of regulatory positions and classifications (...)
On January 22, 2016, the ANSM published a new version of the “FAQ” on regulatory positions and classifications of (...)
- New harmonized standards lists
What changes : New versions of the harmonized standards lists were published on the 10th of July, 2015 :
- INTERNATIONAL NEWS N°08
RUSSIA : New medical devices (MD) nomenclature system complicates MD registration
Since January 2015, Russia has (...)
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Our experts bring you their expertise in dealing with your problems. An innovative approach based on a global vision of the life cycle of the product, we put our expertise to work for your company to meet your needs in: product validation, compliance and marketing, organisation and quality in your business, knowledge and monitoring of the normative and regulatory environment.
advice – training – audit – due diligence – post market surveillance – conformity – regulatory strategy