new technologies
New and Emerging Technologies
Our company brings together the scientific resources of over 200 experts for all types of
- active medical devices
- non-active medical devices
- combination products consisting of medicinal substances or blood derivates and medical devices
- in vitro diagnostics
Furthermore, we can provide expertise and support for manufacturers of advanced therapies medicinal products that utilize medical device components.
Based on this profound expertise we can provide scientific advice and product testing to companies for the development of new innovative products. The successful application for market authorization for new and innovative medical devices depends on straightforward strategic decisions, a well set schedule while considering current legislative requirements and the up to date state of technology. To streamline the process you may use the services of our experts for information and testing as early as during the developmental phase of your new product.
Scientific Advice and product testing may be requested for all types of medical devices. It is prospective in nature and focuses on development strategies. It is our task to give Scientific Advice to industry by answering questions based on the documentation provided by the company in the light of the current scientific knowledge.
Scientific Advice may be given on questions concerning issues related to the
- quality (manufacturing, chemical and biological testing as well as mechanical and electrical safety),
- non-clinical and clinical aspects
- risk management programmes
- functional safety concepts
- combination products
- tissue engineering
- gene therapy and
- nanotechnology
Scientific Advice may be given additionally on issues relating to interpretation and implementation of (draft) EU guidelines and standards.
