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MD squared takes next step to grow its Medical Consultancy for Medical Devices

15 month after MD squared started the journey to support its clients in the Medical Device Industry with Value Creation through Product Claim Management the time has now come for the next step:
MD squared B.V.
( besloten vennootschap ), a private limited company under Dutch law was setup in March and effectively continues as of April 2nd 2018 the business of MD squared (eenmanszaak, or one-person-company under Dutch law).

Claus Schaffrath, founder and consultant at MD squared commented: After setting up the business and starting the first projects more than a year ago, I obtained much encouraging feedback from our clients. Simultaneously it became apparent that Medical Device Companies face growing challenges over the upcomming years to adjust to new Regulatory Requirements, to move to Risk Based Quality Management, and to update the Performance & Safety profile of Medical Devices with adequate Clinical Data.

MD squareds approach to combine regulatory compliance with value enhancing differentiation has been set up with these challenges in mind. Our Product ClaimManagerTM offers structured multi-disciplinary support and helps to make informed decisions on balancing differentiating product claim value against the costs to substantiate it in a regulatory compliant way.

Moving MD squared to a B.V. structure now sets up our business for growth. It shall make it easier to attract like-minded partners and alliancing companies with complimentary competencies and shall help to broaden MD squareds portfolio for our clients in the Medical Device Industry.

What we offer

What we offer

MD squared provides the following Services
  • Business Development and Marketing Consultancy for the introduction of novel products and product categories for the Medical Device Industry
  • Medical Support in Regulatory Strategy and Compliance. 
  • Clinical Evaluation & Validation Support and communication with notified bodies and competent authorities.
  • User Needs Assessment and Product Portfolio Analysis for clinical and economic value creation.
  • Clinical Risk-Benefit Analysis and Post-Market Surveillance Plan for Medical Devices.
  • Adverse-Event-Analysis, Mitigation, Reporting and Follow-Up
  • Workshops, Trainings and Seminars on Product Claim Management for Medical Devices

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MD squared
Boerhaavelaan 33

5644BB Eindhoven

The Netherlands

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