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.

Click here for a quick overview of the subject medical device approval:

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:

EMA Pharmacovigilance
Health care studies
Observational studies
EMA Pharmacovigilance
Medical Biometrics
Approval of Medical Devices
Clinical Investigators
Clinical Trials
GCP Legislation
GCP - Good Clinical Practice
GCP Guidelines
GCP Compliance
Clinical Research Organisation
Contract Research Organisation
Pharmacoeconomics, Health
Pharmacoeconomic studies
Patient Monitoring
Monitoring Clinical Trials
Clinical Monitor
Marketing Authorisation
Medicinal Product Approval
Drug safety
Data management plan
Clinical development
Monitoring investigators
Non-interventional studies (NIS)
Patient recruitment
Phase IV studies
Investigator audit
Investigator qualification
Investigator selection

EMA Pharmacovigilance · Health care studies · Observational studies · EMA Pharmacovigilance · Medical Biometrics · Approval of Medical Devices · Pharmacovigilance · Clinical Investigators · Clinical Trials · GCP Legislation · GCP - Good Clinical Practice · ICH GCP E6 · GCP Guidelines · GCP Compliance · BfArM GCP · Clinical Research Organisation · Contract Research Organisation · PSUR · PSURs · Pharmacoeconomics, Health · Pharmacoeconomic studies · Pharmacoeconomics · Patient Monitoring · Monitoring Clinical Trials · Clinical Monitor · Marketing Authorisation · Medicinal Product Approval · Drug safety · Data management plan · Clinical development · Monitoring investigators · Non-interventional studies (NIS) · Patient recruitment · Phase IV studies · Investigator audit · Investigator qualification · Investigator selection