About VDE Health

VDE Health is the VDE’s platform for regulatory readiness in the healthcare sector. We support manufacturers, operators, software companies, start-ups, research institutions and healthcare organisations in reliably understanding, interpreting and implementing regulatory requirements.

In doing so, we build on the strengths of an organisation that has stood for technical safety, quality and trust for more than 130 years. The VDE combines unique expertise in standardisation, testing, certification, technology assessment and regulatory matters.

What sets us apart: VDE Health is backed not just by a single team of consultants, but by an extensive network of specialists from a wide range of disciplines. Depending on the issue at hand, we can draw on experts from the fields of medical devices, software and AI, cyber security, quality management, clinical evaluation, international regulation, standardisation, and testing and certification.

Why VDE Health?

Comprehensive support rather than ad hoc advice

Regulatory requirements today are intertwined across many specialist areas. The MDR, IVDR, quality management, software standards, cybersecurity, AI regulation, international authorisation pathways and post-market requirements must all be considered together.

VDE Health supports you throughout your product’s entire lifecycle – from regulatory strategy through to quality management and proof of conformity, right through to market access and post-market compliance.

Our aim is not simply to answer individual questions in isolation, but to strengthen your company’s regulatory capacity in the long term.

Trust through experience and independence

The VDE is one of the most established and respected organisations in the field of technical safety and conformity. Our work is characterised by expertise, objectivity and high standards of quality.

Companies place their trust in VDE Health because we assess regulatory issues independently, make risks transparent and develop solutions that are technically sound and sustainable in the long term.

The right experts for every challenge

Modern medical devices combine medicine, software, artificial intelligence, electronics, data processing and international regulation. The requirements are correspondingly complex.

Thanks to the network within VDE, we can bring together the right experts for every task. This gives you access to knowledge from various specialist fields and allows you to benefit from a coordinated approach to your regulatory challenges.

An international perspective

Manufacturers today think internationally right from the start. That is why we do not view regulatory requirements exclusively from a European perspective.

Whether it’s European CE marking, international market strategies, FDA requirements, UKCA or global quality management systems – we support you in understanding regulatory requirements in international markets at an early stage and making the right decisions.

Our aim

We help you to view regulatory requirements not as an obstacle, but as a key to success.

Drawing on VDE’s experience, network of experts and technical expertise, we support you in achieving regulatory certainty, identifying risks at an early stage and shaping the path of your medical device efficiently and successfully.

VDE Health – your partner for regulatory readiness.

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