Medical Device Consulting
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
> Commercialization: Accelerating the time to market for innovative new
> 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|
Our integrated approach to market access and adoption helps you achieve your commercial objectives. Let Cmed help you make a positive impact on patients’ lives.