Bring your medical devices to market safely

Do you develop, operate or market technical devices, systems or software for medical or health-related purposes?

VDE Health supports you in meeting all regulatory requirements and bringing your medical devices to market safely, swiftly and in compliance with regulations.

From the initial idea through development, conformity assessment and market access right through to market surveillance, we are at your side with the right expertise. This enables you to lay the foundations for successful authorisation, minimise regulatory risks and gain confidence in your decisions.

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.

Expertise

Would you like to gain a better understanding of regulatory requirements, standards and current developments in the fields of medical devices, software or digital health?

In the ‘Knowledge’ section, VDE Health provides practical information, specialist articles, analyses and the latest insights into regulatory affairs in the healthcare sector. This helps you navigate a complex regulatory environment, stay informed about relevant changes and establish a sound basis for safe and successful decision-making.

Events

Would you like to expand your knowledge of medical devices, software, AI or regulatory requirements in a targeted manner and exchange ideas with experts?

VDE Health’s specialist events offer up-to-date information, practical insights and direct dialogue on regulatory issues in the healthcare sector. Whether it’s a seminar, workshop or specialist forum: we help you to better understand new requirements, assess developments at an early stage and gain valuable insights for your practice.

Receive the latest information on regulatory affairs relating to medical devices and our specialist events
(Note: The newsletter is in German)