Do you develop hardware or software for medical or health-related purposes and want to place it on the European market? VDE can help you here with its many years of experience. We assist you to bring your new product onto the regulated market safely, quickly and with as little effort as possible. Our focus is on active medical devices including medical software. In detail we support you on:
- Regulatory strategy and effort planning
- Definition of the intended purpose
- Qualification as a medical device
- Risk classification of the product
- Analysis of all relevant laws, standards, guidances, and other documents
- Implementation of the quality management system
- Implementation of the risk management system
- Implementation of the clinical evaluation
- Implementation of post-market surveillance
- Fulfillment of the General Safety and Performance Requirements
- Preparation and updating of technical documentation
- Implementation of the required registrations
- Preparation of instructions for use and labeling
- Selection of and cooperation with a Notified Body
- Declaration of conformity and CE marking
If you first need a dedicated requirements and process plan for your medical device, combined with an estimate of the costs and duration of the approval of your medical device, we recommend our "CE Roadmap for Medical Devices".
Many problems can be avoided at an early stage if regulatory requirements are taken into account right from the start and undesirable developments are avoided. At this point, the CE roadmap provides essential information and also helps to correctly assess the economic risks of the project.
Smaller, young or industry-new technology companies also face particular challenges when it comes to medical device approval. Often, the projects are financed by external investors. Here, the CE roadmap helps to make correct assumptions when presenting the financing and to create confidence among the investors. Often, the effort required for approval is significantly underestimated.
In the case of medical software, we are particularly concerned with the aspects of cybersecurity and artificial intelligence. In both cases, there are specific requirements for approval.
On the one hand, we have developed a special cybersecurity risk management system for medical devices, because mandatory risk management must also address risks arising from cyber threats. In particular:
- MDR-compliant processes for integrating cybersecurity management into risk management,
- MDR-compliant processes for post-market cybersecurity risk management, and
- tailored processes, with the goal of implementing only those cyber risk mitigation measures that are actually required.
Second, we have developed an approach for efficient market access for artificial intelligence (AI)-based software. AI medical devices are characterized by the AI model and training data in addition to the software code. This raises specific issues, e.g., generalizability, transparency, and representativeness. We offer specific support in bringing AI medical devices to market in a compliant manner:
- Product-specific analysis of all regulatory AI requirements.
- AI-adapted implementation of the quality management system
- AI-adapted extension of software lifecycle processes
We also offer tailored in-house workshops specifically for your company to provide you with the necessary regulatory know-how.
