ISO-13485 Certificate

Medical devices are strictly regulated by European directives to ensure efficacy and safety of the patient. With the aim to comply with the medical device market, the Institute for Human Centered Engineering HuCE has established the sub-group HuCE-microCert which is ISO-13485 certified. HuCE is committed to closely collaborate with SMEs in applied research as well as in design and development of medical products. A certified cleanroom ISO class 7 has been setup for manufacturing of medical devices requiring a controlled environment.