For over 20 years Dr. Oestreich + Partner GmbH focus on all services required to place a new medical device on the market and to keep it on the market. We provide regulatory and quality compliance, clinical evaluation, data management and marketing services to manufacturers of medical devices.
Clinical development MPG
Medical devices with a high risk category often need clinical trials to insure safety, especially if there are no data from clinical studies with comparative products in the literature.
Medical devices are classified into four risk classes: I, IIa, IIb and III (depending on the risk in the application). The classification of a medical device depends on its intended use and belongs to the responsibility of the manufacturer. During our long term experience, we have conducted projects with medical devices in the categories: consulting, strategic planning, clinical research, project management and co-ordination covering the following market segments:
- Non-active, non-implantable medical devices
- Non-active implants
- Active implantable medical devices
- Active medical devices
Our services help to shorten development time, obtain CE-conformity and approval more efficiently and in a timely manner. We support our customers in the areas of R&D, regulatory affairs, quality assurance, vigilance, commercialization and strategic marketing planning bringing their enterprise a successful completion.
Our customers are
- Medical device manufacturer
- InVitro diagnostics companies
- Start-up companies