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 ?
- Ethylene oxide sterilisation
Changes: The EN ISO 11135:2014 standard was published on July 16, 2014: “Sterilisation of health-care products - (...)
- An answer to a recurring question: In which language do I write my MD (...)
Context: A simple question leads to a simple answer…. Download the Team NB* publication on: www.team-nb.org. This (...)
- An essential guide for IVD MD suppliers: Position paper, September (...)
Context: In September, 2013, the SIDIV (French Syndicate of the In Vitro Diagnosis Industry) published a guide to (...)
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