Encotec Schmid KG
Country headquarter:
Austria.
Market presence:
Europe.
General description:
en•co•tec is an engineering office and a business consultancy specialized on development, certification and quality management for medical devices. We are consulting leading manufacturers and suppliers in the medical device sector and pool extensive experience in development and certification of innovative medical devices.
Areas of regulatory/reimbursement support:
- Development of medical devices and IVD.
- Quality management ISO 13485.
- CE- and FDA-marking for medical devices and IVD.
- Risk management ISO 14971.
- Support for the new MDR / IVDR.
- Consulting & Academy.
https://ec.europa.eu/digital-single-market/en/ehealth-and-ageing
The eHealth Hub project has received funding from the European Union’s Horizon 2020
Research and Innovation Programme under Grant Agreement No727683.