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 Cmedâ€™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|