Description: We provide legal responsibility for medical devices with regard to design, development, manufacturing, and distribution under MDR 2017/745 as well as authorized representative services for medical device manufacturers located outside of the EU. Contract development for medical device software and combination products.
artificial intelligence (4395) medical devices (592) ivd (131) quality management system (61) medical device software (4) en iso 13485 (2) legal manufacturer service (1) mdr/ivdr (1) ec rep service (1) contract development service (1)
Your partner for legal responsibility for medical devices with regard to design, development, manufacturing, and distribution under MDR 2017/745 and IVDR 2017/746.
NEXTEC medical GmbH is an EN ISO 13485:2016 certified company. With over 25 years of experience in medical device regulatory affairs, we are your trusted partner of choice when it comes to acting as Legal Manufacturer or European Authorised Representative as well as Contract Developer for Medical Device Software with or without the use of Artificial Intelligence.
We act as your Legal Manufacturer according to the obligations laid out MDR/IVDR Article 10