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MD squared 's - Product ClaimManager

Getting to the right claims - and getting your claims right

The Product ClaimManagerTM provides a toolkit with three modules to stepwise guide to the essence of the following questions:

  • What is your Customer Target Group and what are their underlying needs you want to address?
  • What is the implicit tension for your Customer Target group resolved by your Medical Device?
  • What is your product’s intended use and indications for use specifically for this target group?
  • How can you formulate the proposition of your device in differentiating benefits (technical, clinical or economic claims)
  • How do you demonstrate these claims in a regulatory compliant way?
  • Which clinical areas and which countries are you targeting in which order?

Define where you compete with the Product ClaimManagerTM’s ClaimSpacer.  It illustrates the degree of differentiation, which a portfolio of intended claims holds over the competition for your Customer Target Group.

The ClaimValuer determines how you compete and guides you through a systematic assessment of costs and value of specific target claims for a given indication for use. This helps setting an effective Claim Substantiation Plan.

Lastly throughout the life cycle of your Medical Device the ClaimMonitor delivers on making a difference in your Product Claim Strategy and building an initial Product Claim Roadmap and Product Claim Sheet in the context of an explicitly chosen Regulatory Strategy.

 Regulatory Support  Ÿ Ÿ•   Medical Competence   •   Value Creation •   Services

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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