Making medical device development and certification understandable
Going from a medical idea to a product in the hospitals or with patients at home is a great journey. This journey we want to accompany you where our experience with many medical devices will prevent you from reinventing the wheel all over.
Working from an engineering background in electronics and software, with experience in quality management systems and medical device certification we can support you in most aspects of the medical device development and commercialization.
We have supplied to our customers:
- Innovative designs which have resulted in patents for our customers.
- Risk management training en implementation in accordance with the ISO 14971.
- Specification, architectural and project management during the development.
- Training of development staff in accordance with IEC 60601-1 and IEC 62304.
- Implementation of quality management systems according to ISO 13485.
- Full support with notified bodies from application forms to approved technical file.
- Time to market of 18 to 30 months for projects run by us.
Contact us under info@MedTeCo.nl for any questions and challenges that you have.