To comply with the validation, the equipment must be manufactured according to a validated process by an ISO13485 certified company.

In the development of new products or preparing prototypes for manufacture in this industry, broad understanding and experience is often imperative in addition to the ISO 13485 certification. Through our wide experience and large network of universities, research agencies, suppliers and partners, we always have access to the necessary knowledge. However, through acting as your project manager, we are not just able to develop your product. We are also glad to take on the manufacture, assembly and final testing for you. Because for this too we have all the necessary in-house knowledge, experience and facilities.
 

References


Finameter medical systems – fingertip blood pressure meter


Medical workshop – various instruments for ophthalmology