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 ?
- AUSTRALIA – TGA – New requirements for certain conformity assessment
The Therapeutic Goods Administration (TGA) announced on its website that there would be significant (...)
- INTERNATIONAL NEWS N°03
USA - Publication of the "Guidance on Evaluation of Sex-Specific Data in Medical Devices Clinical Studies” - August (...)
- Ethylene oxide sterilisation
Changes: The EN ISO 11135:2014 standard was published on July 16, 2014: “Sterilisation of health-care products - (...)
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