Medical Device

Medical Device

Maximize your ROI by ensuring the optimum pathway to market. Cmed’s consultants have extensive experience with medical device companies from small, emerging firms to the largest global organizations. The Cmed team’s expertise in various medical technologies includes projects from Class I to Advanced Therapy products and helps from conception, development and through licensing/commercialization in Europe, the US and Asia Pacific.

Get the most value from your device assets with Cmed’s integrated commercialization, innovation and development strategy. We are prepared to help with:

  • Innovation: Creating the environment for innovation to flourish in the face of increased competition.
  • Development: Fine-tuning product and process development, marketing and regulatory capabilities.
  • Commercialization: Accelerating the time to market for innovative new products.
  • Value maximizing: Increasing the market value of existing and new products.

Our proven services

Regulatory Consultation Product classification; regulatory strategy; unique and combination products; due diligence; and emerging regulatory issues.
Regulatory submissions IDE, 510(k), PMA, 513(g), European CE marking in Class III medical devices, and post-marketing submission support (PMA supplements, 510(k)s for device changes, annual reports, and post-market studies).
FDA and European agency interactions Pre-510(k) and pre-IDE meetings; Competent Authority scientific briefings; advisory panel preparation and support; dispute resolution; and administrative appeal.
Clinical study design and evaluation Patient population identification, study site evaluation, endpoint selection, statistical analysis plans, study reports and manuscripts/publication development.
Global regulatory filings All required filings

Want to learn more?

Please feel free to contact us if you would like to learn more about our skills and experience. We are friendly, open and here to help.

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