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 ?
- Advertising in favour of Medical Devices (DM) and Medical Devices of in (...)
New : new provisions aimed at regulating the advertising of medical devices (MD) Medical Devices and In Vitro (...)
- EN ISO 14971:2012
Release of the new version of the Harmonized Standard EN ISO 14971:2012 Risk Management for Medical Devices. (...)
- Unique Device Identification
What’s on the move : DM identification requirements are simultaneously changing throughout the world. In July (...)
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, organization 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