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.

The conformity of medical devices is not achieved by creating individual documents after the fact. It must be incorporated early on into the intended use, product architecture, data, development processes, clinical strategy, quality management, and market surveillance. Our key topics are:

• Regulatory Strategy and CE Roadmap
• Intended Use, Qualification, and Classification
• Quality Management According to ISO 13485
• Roles and Responsibilities in Medical Device Law
• Risk Management and Product Safety
• Technical Safety and Relevant Standards
• Usability and Human Factors
• Clinical Evaluation, Clinical Trials, and Evidence
• Labeling, Instructions for Use, and Product Information
• Medical device software, AI, and the EU AI Act
• Cybersecurity and the software supply chain
• Regulatory and compliance software
• Technical documentation and regulatory evidence management
• Change management
• Post-market surveillance, vigilance, and CAPA
• European market access under the MDR and IVDR
• International market access, particularly in the U.S.
• Reimbursement and access to standard care

Services

As a strategic business unit of the VDE, VDE Health addresses regulatory issues in medical technology, provides expert knowledge, and assists with the interpretation and implementation of regulatory requirements. The services described below are tailored to specific technical and regulatory tasks and are agreed upon on a case-by-case basis depending on their nature and scope.

Market Access Compass
Development of a technically sound development and market access strategy

CE Roadmap
Roadmap for preparing for testing, certification, conformity assessment, and CE marking

Gap Analysis
Analysis of the current status of regulatory preparedness and identification of necessary actions

Regulatory Support
Support with the practical implementation of regulatory requirements throughout the entire product lifecycle​​​​​​​

In-House Training
Providing practical, specialized knowledge on regulatory requirements

Do you have any questions?