Ein medizinischer Roboterarm im Operationssaal
CE Roadmap for Medical Devices
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Technologie-, und Innovationskonzept
CE conformity for AI-based software in medicine with BAIM
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Tablet mit medizinischen Informationen
Cybersecurity risk management for medical devices
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VDE Health
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Get your medical device to the market safely

The range of medical technology is enormous. Medical devices for surgery, operating theaters, endoscopy, dentistry, medical implants and laboratory diagnostic equipment are just a few examples. Medical technology is also digital. Medical information systems and apps, e-health, digital health applications, medical AI, wearables or medical robots are all part of healthcare.

It is crucial that all medical devices must function safely, reliably and performant and must comply with all legal requirements. Safe, useful and reliable medical devices protect patients and users from harm, as well as manufacturers and operators from reputational damage. Failure to comply with the applicable regulations results in liability risks for both manufacturers and operators of medical devices.

The development of new medical devices is therefore challenging. Regulatory requirements make it difficult to access markets and must be met. The requirements for European CE marking in particular have become very demanding and difficult to implement. Qualified experts are needed to navigate the many laws, standards, directives and regulations.

We provide advice on how you can bring your medical devices to the European market quickly and safely. Benefit from our expertise in the field of medical device regulation. Make the European market launch of your product as efficient as possible. VDE tests and certificates confirm and document the quality and conformity of your medical devices.

We are specialists in the entire field of active medical devices, including medical software. Our focus is on:

  • Active medical devices for dentistry, e.g. dental treatment equipment
  • Medical technology for operating rooms and intensive care units, such as endoscopes and patient monitoring systems
  • In-vitro diagnostics and laboratory medicine
  • Medical software, including health apps, AI software and cybersecurity

VDE Health Areas

Annual Conference of the German Society for Biomedical Engineering

The international biomedical engineering community meets once a year at the Annual Conference of the German Society for Biomedical Engineering and discuss the most important topics from research and development in medical technology. Join!

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Hand eines Arztes mit modernem PC-Interface

Healthy & active through technology

Health and technology are closely intertwined, especially where technology is crucial to the success of prevention, diagnosis, therapy or rehabilitation. DKE Health develops safety and performance-related specifications for the protection of patients, staff and other affected persons.

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Regulatory Affairs + Market Access

VDE offers guidance on approval and market access for medical devices and software. Get your device to the EU market safely and quickly.

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Business IntelligenceKPIs

Medical technology

Specific safety requirements are placed on medical and laboratory technology products. With VDE tests and certificates, you can document the quality and conformity of your medical and laboratory equipment. The VDE Institute offers a range of different certifications and has the corresponding accreditations.

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Testing and certification of medical technology products by the VDE Institute