Qmed Academy

Getting your medical device to market

Are you a medical device specialist working with clinical and regulatory affairs or quality assurance? Then the Qmed Academy is for you! Bringing a new medical device to the market, requires that you master certain skillset and competences – and can document them. As a start-up or even a larger organisation, it might be difficult to find the right path and develop the documentation required to obtain market approval and the company is at risk of losing important deadlines. The road to approval is long and difficult, but at the Qmed Academy, we will show you how to get there.

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World-Class Regulatory Services and Strategies

Finding your way through the regulatory landscape can be difficult as it requires up-to-date knowledge, experience and contacts. Our strategic consulting team guides you along the most efficient and optimal strategic path to CE-mark, device registration and/or approval outside EU and support in building up and use post market surveillance. As the industry moves from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) it is important to understand the implications on the regulatory requirements and timescales. Our team are available to support you through this transition.
Regulatory Services
  • Classification and Regulatory Strategy with reference to the Intended Use and Commercial Markets
  • MDR Gap analysis
  • Project Definition
  • Risk Management
  • Build up Design History File and Summary of Technical Documentation (STED) with all aspects of the Technical File
  • Support in selection and handling of materials and in preparation of Biological and Clinical evaluations based on literature studies
Submissions, Notified Bodies and Regulatory Authorities
We take care of device approval submission, maintain efficient contact with Notified Bodies and relevant Regulatory Authorities.
Post Market Surveillance
We take care of vigilance, post market clinical follow-up and update of the technical file.
Global Regulatory Community

Our consulting team has an in-depth knowledge of regulatory systems world-wide. Combined with our knowledge of the notified bodies and regulatory authorities, this means that we can help you with device registration and/or approvals quickly and efficiently.

Contact us to find out more about Regulatory Affairs