MRM | Medical Risk Management

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 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' (IBSS) concept by utilizing this as 'Full Service Life Cycle'  - model. Clients will benefit from our expertise, as seen in the innovative solutions we provide.

FullServiceModel MRM

MRM provides the best personal support for implementing excellent solutions to your business challenges, such as e.g. contol of supply chain, meet European and US regulatory requirements, control of product liabilities.  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 offers supply chain services such as Transport Management, Inventory Management and Value Added Logistics.

MRM is ideally located inThe Netherlands, and does have good entry facilities to have easy access to all European Union member states.  Further, MRM has a strategic partner who is centrally located in the USA. 


  • MDR: Changes in the International Clinical Investigations Standard
    Many European and IMDRF documents refer to ISO 14155 as a ‘conformity’  standard. So it is an important tool to demonstrate compliance with the EU regulatory requirements. Especially when performing clinical evaluation to demonstrate and provide clinical evidence what is needed and required to support defined medical claim of the…