Your partner for legal responsibility for medical devices with regard to design, development, manufacturing, and distribution under MDR 2017/745 and IVDR 2017/746.
Contact UsNEXTEC 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
NEXTEC provides the complete MDR / IVDR and EN ISO 13485 infrastructure to meet the requriements for acting as the Legal Manufacturer with sufficient processes for transferability of your documentation at any time.
Get in contact with us for further information about our welcome and onboarding process.
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We act as European Authorised Representative according to MDR/IVDR Article 11
NEXTEC provides the full MDR / IVDR and EN ISO 13485 infrastructure to meet the requirements for acting as the European Authorised Representative which is always required in case the Legal Manufacturer resides outside of the EU and intends to place a product on the European Market. We will support you in all relevant activities, including the registration and communication with Authorities.
Get in contact with us for further information about our welcome and onboarding process.
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We develop Medical Device Software with or without the use of Artificial Intelligence
You have a product idea that requires a software solution and you do not have the expertise available. Product ideas could be for example:
NEXTEC provides the framework of a software lifecycle process as well as a validated software development platform compliant with MDR / IVDR and EN ISO 13485 requirements and we can support you in developing either Medical Device Software or software used for internal QM-related processes.
Get in contact with us for further information about our welcome and onboarding process.
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NEXTEC is part of a solid and well established regulatory company group, initially founded in 1994 by Dr. Regenold.
Our regulatory affairs experts can look back up to 20-40 years of experience and +1000 products supported
Due to our company group build-up we can cover all aspects of categories, be it Medical Devices, IVD, Drugs, or Drug Combination Products.
Our companies are all in-house and create strong synergy effects, and allowing us to adapt to your regulatory and resource needs
Managing Director
Over 3 decades Hans collected profound expertise in the field of QM and Regulatory Affairs for medical devices and IVD. Almost 15 years in MD and IVD industry plus several years with a Notified Body build the fundament for the practice-oriented knowledge in all different facets of reguatory business. In 2009 Hans was co-founder of CEplus.
Person responsible for regulatory compliance (PRRC)
Marcel Wöllbrink has over 10 years of experience as a Regulatory Affairs Expert in the fields of non-active medical devices, drug registrations (CMC – Chemistry, Manufacturing & Control), auditing with regard to EN ISO 13485 and ISO 17025 and the establishment of quality management systems according to EN ISO 13485. As managing director and head of the team for non-active medical devices, Marcel is specialised in supporting CE marking for substance-based medical devices (borderline products) and combination products (drug device and device drug).
Director Regulatory Affairs
Oliver Hilgers is a Regulatory Affairs Expert for Medical Device Software and looks back on +10y of experience and over 300 software products supported within the framework of CE-marking. Oliver is member of several European Working Groups for Medical Device Software in order to create guidances for manufacturers. In addition he is official trainer for Medical Device Software at the Notified Body Academy of TÜV Rheinland as well as mentor at EIT Health and numerous Innovation Hubs and Accelerators helping companies to place innovative software on the market fast and safe.
