Approval of Medical Devices
Approval of Medical Devices in accordance with national medical device legislation
With regard to the increasing demands, constraints and legal requirements (medical device legislation), Dr. Oestreich + Partner GmbH is a competent partner for successful realisation of medical device approval. On behalf of our customers, we work to an objective-driven project plan to complete the conformity assessment procedure in order to determine the risk classification, as a prerequisite for the CE mark approval and certification by the notified body. We carry out a cost-benefit analysis at each planning stage of the medical device approval process with the interests of our customers uppermost.
The company Dr. Oestreich + Partner GmbH has been successfully operating as a full-service CRO (Clinical Research Organisation) in diverse areas and indications in clinical research. Our highly qualified employees are experts that have acquired their skills through year-long employment in international companies, academic institutions or hospitals and have further honed their skills by working at Dr. Oestreich + Partner GmbH. Through our team we, therefore, provide comprehensive and bundled competencies in both the medical and technical areas for the approval of medical devices in Europe in accordance with the EU Directive 93/42/EEC.
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Approval of Medical Devices using web-based documentation systems
We create and prepare all the necessary documents for the approval of medical devices (active and non-active) for our customers from protocols through to reports on assessments and provide full services for clinical trials on medical devices of all risk classes.
As required, we also manage the liaison with the appropriate institutions and authorities to ensure as rapid medical device approval as possible. We also manage license applications for the marketing of medical devices or the publication of medical and scientific information, in addition to postal and electronic mailing.
In our training centre in Cologne, we conduct regular training, in the form of seminars or individually tailored training sessions, for employees with research, marketing and sales backgrounds. Our professional and experienced coaches and instructors also provide training and information sessions on topics such as the approval of medical devices.
A general overview of our range of services for the approval of medical devices can be found here: