The event is a free online event. Contents of the event:
- Overview of the related regulatory requirements
- Safety concepts
- Testing requirements
- Labelling requirements
- Related Usability and Home healthcare requirements
Medical technology products are subject to exceptionally high safety requirements, since it is literally about life and death. They are used for diagnostics, monitoring, or therapy for illnesses. As a result, they increase the efficiency of healthcare, improve quality of life, and keep people alive. It is indispensable that medical products be used safely and reliably in spite of extreme conditions. The VDE Institute helps you comply with the regulatory guidelines and obtain internationally recognized certifications.
In medical technology, the utilized products are required to meet regulatory and normative requirements. With the expertise of our VDE experts, our years of experience and our extensive scope of accreditation and recognition in the field of medical technology, we offer you various services so that your medical product can meet current market demands – even as early as during the development process. By doing so, differences can be quickly detected and resolved. Not only does this save money during product development but also time during the subsequent certification.
Treatment units constitute the basis for successful and efficient dental treatment. Furthermore, they lay the foundation for a positive patient experience.
Only through professional patient positioning can complex surgical interventions be performed with a high level of patient safety. Even ergonomic aspects of the persons being treated must be taken into account here.
Safely measuring and displaying physiological parameters are the foundation for successful patient care.
These minimally invasive diagnostics and treatment techniques result in shorter stay times for patients and reduce the risk of infection.
Nowadays, there is hardly any medical product that can make do without firmware and/or software. An increasing number of apps are also standalone medical products in their own right. We verify compliance with normative and regulatory requirements on your behalf.
Reliable and safe laboratory equipment is required for safe laboratory operation and optimum care with clean medical products and sterile materials.
The basis for a high level of patient safety is reliable diagnostics in the laboratory. To protect the user group of this equipment, the VDE Institute offers testing services for it.
For years, the medical technology industry has been characterized by a high level of innovative force and is number one in patent applications. Its fast-paced development, which is also due to the complexity of digitalization, continuously entails new normative requirements for medical products. This is why early collaboration with the VDE Institute is recommended.