Market Access for Medical Devices and Software

Are you developing software or hardware for medical or health-related purposes and want to bring them to the market? Then you face lots of laws, regulations, directives, guidelines and standards, since you must prove that your product is safe and fulfills its purpose before you can place it on the market. This is where we can help you with our many years of experience. Together with you, we bring your new product to the regulated market safely, quickly and with as little effort as possible.

Placing medical devices and software on the market

We consult and support you in all matters relating to the approval and certification of medical devices. Our focus is on active medical devices including medical software. In detail, we consult you on the:

  • regulatory approach and effort planning
  • formulation of the intended purpose
  • qualification as a medical device
  • risk classification of the medical device
  • analysis of all relevant laws, standards 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 (PMS)
  • fulfillment of the general safety and performance requirements
  • preparation and updating of the technical documentation
  • implementation of the required registrations
  • preparation of instructions for use and labelling
  • choice of and cooperation with a Notified Body
  • declaration of conformity and CE marking

Our ‘CE roadmap‘ allows a precise statement of the regulatory requirements for a particular product, the costs and the timelines. More information at:

CE roadmap for medical devices:
What are the requirements for approval and what are the costs?

Cybersecurity as part of the risk management

Implementing all cybersecurity requirements as efficiently as possible poses major challenges for manufacturers. The European Medical Device Regulation (MDR) explicitly requires a medical device manufacturer to carry out risk management. This risk management must also address risks arising from cyber threats. This is exactly where we offer help with our ARGOS process:

  • MDR-compliant processes for integrating cybersecurity management into risk management.
  • MDR-compliant processes for post-market cybersecurity risk management
  • Tailored processes, with the aim of implementing only those cyber risk mitigation measures that are actually required

More information:
Cybersecurity risk management for medical devices: ARGOS

Market access for AI-based medical software

Medical devices with AI (artificial intelligence) software must meet specific requirements for market access. AI software is characterised by the AI model and training data in addition to the software code. This gives rise to specific questions, e.g. on generalisability, transparency and representativeness. With our BAIM process, we offer support in bringing AI medical devices to market in a compliant manner:

  • device-specific analysis of all regulatory AI-requirements
  • AI-adapted implementation of the quality management system
  • AI-adapted extension of the software lifecycle processes

More information:
Efficient market access for artificial intelligence (AI)-based software: BAIM

In House Workshops

We offer several workshops and consultation days on a regular basis. In order to provide you with the necessary know-how, you can book our experts for a (online) in house workshop. Find out more about our tailor-made offers.

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