Developing Medical Devices in Compliance with Regulatory Requirements

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

VDE Health helps you understand and interpret regulatory requirements from a technical perspective and implement them in the development and conformity assessment of medical devices.

From the initial idea through development, conformity assessment, and market access all the way to market surveillance, VDE Health brings together technical expertise and identifies relevant regulatory issues early on. This provides guidance and a technically sound foundation for safe, compliant, and innovation-friendly development and market access processes.

About VDE Health

VDE Health is the VDE’s strategic business unit dedicated to regulatory issues in medical technology. We identify relevant regulatory topics and provide support in accurately understanding, interpreting, and implementing regulatory requirements.

In doing so, we build on the strengths of an organization that has stood for technical safety, quality, and trust for more than 130 years. The VDE combines expertise in standardization, testing, certification, technology assessment, and regulatory matters. VDE Health helps to thoroughly analyze complex regulatory requirements for medical technologies, make knowledge accessible, and reduce regulatory barriers to innovation.

What sets us apart: VDE Health is backed by an extensive professional network of experts from various disciplines. Depending on the topic and task at hand, we can draw on expertise in the fields of medical devices, software and AI, cybersecurity, quality management, clinical evaluation, international regulation, standardization, and testing and certification.

Expertise

Would you like to better understand 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, expert articles, analyses, and the latest insights on regulatory affairs in the healthcare sector. This helps you navigate a complex regulatory environment, stay informed about relevant changes, and establish a solid foundation for making safe and successful decisions.

Events

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

VDE Health’s professional 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 expert forum, we help you better understand new requirements, assess developments early on, 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)