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News

(EU) Regulation 2024/1689, the so-called "AI Act" (AIA), and the MDR/IVDR
Software (including AI) for medical purposes is regulated in Europe and the United Kingdom as a medical device. It requires comprehensive assessment before being placed on the EU and UK market under Medical Device Regulations (MDR) and the EU In Vitro Diagnostic Medical Devices Regulation (IVDR). The European Union (EU) has introduced new legislation on…

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Contact our office:

+31653316900
info@medical-risk.com
P.O. Box: 10110, 5060GA Oisterwijk (The Netherlands - EU)

QNET LLC (Minnesota, US)

QNET Ltd. (England, UK)

QNET CH-REP GmbH (Switzeerland)

QNET B.V. (The Netherlands - EU)

About

Service Application Form

MRM offers 'Integrated Business Solutions and Services' as a modular full service concept in consultancy, training and project management, such as i.e. QMS (ISO and QSR), CE-technical file(s), risk management, clinical investigation, validation, logistic solutions, covering product liability, etc.

We are a dedicated team of independent (medical, technical & regulatory) professionals. Based on our expertises, skills, and track records we've developed the concept of Integrated Business Solutions and Services (IBSS) as a full service model. Not the model is unique but the multidisciplinary approach and methodology which leads to an add value for our clients.

As consultancy firm we're relative young, but individual we do have an significant track record by successful servicing individual clients, Notified Bodies Certification Institutions, Authorized Representative Agencies, critical stakeholders, etc.

Please do not hesitate to contact our office for more information of our approach and our professionals.

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