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 ?
- USA - The eMDR : A new medical device electronic reporting system
According to the Medical Device Reporting regulation, 21 CFR 803, manufacturers, importers, and device user (...)
- New harmonized standards lists
Changes : New versions of the harmonized standards lists were published on the 16th of January, 2015.
- Medical prescription assistance software within health establishments : (...)
Changes : From the first of January 2015 all medical prescription assistance software used within health (...)
Nexialist, a consulting company, specialising in the development and marketing of medical devices and medical innovations will assist you in your projects.
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