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 ?
- CANADA – Classification of the Drug and Medical Device Combination (...)
On the 21st of July 2014, the list of combination products classified as drug or device was updated. This (...)
- End of the count-down for the UDI (Unique Device Identification) on 24th of (...)
As of the 24th of September 2014 a UIN (Unique Identification Number) is obligatory for the US market.
In June (...)
- INTERNATIONAL NEWS N°01
EGYPT - Future application of ISO 13485: 2012
On April 29th 2014, the Ministry of Health, Central Administration (...)
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