Checklist AR

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Checklist 'How to Select you AR'


	Does have your (potential) AR expert knowledge of European regulatory requirements? i.e. evidence of adequate education, years of experiences, records of continue training as IRCA registered auditor, etc., to demonstrate adequate regulatory competence. Preferable minimum seven years of experiences. Verifiable via IRCA registration dbase. Invalid Input
	Does have your (potential) AR professional clinical and medical expertise? i.e. physicians, M.D., healthcare scientists, who are registered in the national dbase of Ministry of Health in compliance of 2005/36/EC. Verifiable by professional record eg. #GMC, #BIG Invalid Input
	Does have your (potential) AR an word wide coverage of liability indemnity in case of negligence, error and omissions? Verifiable by Certificate of Insurance. Invalid Input
	Does have the your (potential) an additional service to provide Free Sales Certificates (FSC) which are legalized or do have an apostille? Invalid Input
	Does have your (potential) AR an infrastructure to notify and register your products to i.e. NSIS, A.E.M.P.S., ansm, FABDM dbases? Without these registrations it will be difficult to do business in the public sector of specific member state. Invalid Input
	Does have your (potential) AR a service to offer you clinical trial coverage (clinical trial insurance) to protect patients, and medical professionals from adverse events during an RCT caused by an non CE marked medical device? A clinical trial insurance is in many MS mandatory! Invalid Input
	Does have the your (potential) native speaking employees under contract, which may be relevant in communication with National Competent Authorities (NCA). We're able to provide you English, German, French, Dutch, Portuguese, Italian, Polish, and Spanish. Invalid Input
	Does have your (potential) AR an Qualified Person or Responsible Person in their service? Be alert on the specific EU competence requirements! Invalid Input
	Is your (potential) AR adequate ready to support you to be in compliance of the new MDR, IVDR and or ISO 13485:2016? Invalid Input
	(Optional) Is your (potential) AR a member of EAAR? Invalid Input
Email	Please give your email
Your message	Invalid Input
(*)	Refresh Invalid Input

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(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:

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

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QNET B.V. (The Netherlands - EU)

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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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