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 ?
- JAPAN – Partial amendments to the Order for Enforcement of the (...)
The amendment of the Pharmaceutical Affairs Act will result in changes on related legislation to implement (...)
- CHINA – CFDA: Regulations for the Supervision and Administration of Medical (...)
Regulations on medical devices in China has been revised (State Council Decree No. 650) to enhance the (...)
- INTERNATIONAL NEWS N°02
NEW ZEALAND – Changing Medical Device and Drug definitions
Medsafe, New Zealand Medicines and Medical Devices (...)
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