Encotec Schmid KG
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.