MRM | Medical Risk Management

MRM is a experienced and successful player in the niche market of Healthcare, Medical Technology, Life Sciences, and Clinical Evaluations. Our vision is to deliver integrated business solutions and services by utilizing our business concept of ‘Total Service'. Clients will benefit from our expertise, as seen in the innovative solutions we provide.

MRM provides the best personal support for implementing excellent solutions to your business challenges.  We are experienced with regulatory compliance, submission, and training, such as meeting the EU and US Regulatory Requirements for CE-registration (MDR, IVDR), FDA approvals e.g. 510(k), PMA; and Quality Management Systems e.g. ISO 13485, QSR, Business Continuity, Supply Chain Quality Assurance.

MRM enables access to the EU market with Authorized Representation (AR) and Qualified Person (QP) services, especially considering existing and upcoming changes of European Regulations. MRM is establishing access to the US market representation in the USA.

MRM supports organizations by identifying operational, strategic, financial, and product liability risks. We manage these risks by implementing customized solutions employing the most effective risk mitigation, risk transfer, and advanced risk solutions. These solutions go beyond traditional programs to encompass strategies that help achieve our clients objectives. We forge powerful alliances and provide excellent solutions for our clients objectives, protection, benefit and corporate endurance.

MRM offers supply chain services such as Transport Management, Inventory Management and Value Added Logistics.

MRM is ideally located inThe Netherlands, which provides easy access to all of the European Union.  Further, MRM has a representative centrally located in the USA. 

News

  • Independent Authorized Representatives facing additional liabilities
     (June 19, 2015) Following the public availability of the compromise Council position on the new medical device regulation, discussed and approved at the 19 June 2015 EPSCO meeting - unless further changes are made during the trialogue process - Authorized Representatives (AR's) who are independent from the supply chain now…

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