Clinical Evaluation Medical Devices - HPZenner
Clinical Research Organisation | European Clinical Evaluation Report Services | By certified German Medical Doctors | According to MEDDEV 2.7 / 1 Rev. 4 and MDR | Regulatory partner of the medical device industry | We are based in Germany
Tailored for you by experienced German Medical Doctors from most medical specialities.
Our focus is your time to the market.
Notified bodies are increasingly expecting Medical Doctors as clinical evaluators
This is due to the stricter clinical requirements of the new EU Medical Device Regulation (MDR) of 2017. The current clinical procedures for CE certification according to the German MPG and the European guidelines MDD / AIMDD / IVD expire in 2020. Old certificates end no later than 2024: more...
HPZenner Clinical Evaluation Reports are formulated and signed by board certified German medical specialists.
Our MDs can also assist you with a constructive review of existing or pre-formulated documents.
Our service areas for manufacturers
Twelve further clinical fields of the manufacturer's activity - for all twelve we are available with Clinical & Scientific Advice and Support from the product idea through the approval to distribution.
The entire development period of a medical device, marketing and sales are subject to further clinical questions and action areas and can be clinically supported by us beyond the legal requirements.
Waiver of a clinical evaluation
Medical monitoring of the conformity procedure
Medical comparison with risk management
Distribution channels / reimbursement
Our seven proprietary implementation modules as intelligent tools for customized solutions
Our proprietary implementation modules cover all the typical questions of manufacturers - from the initial consultation on idea, patenting and development start to gap analysis, clinical advice & support, clinical evaluation including clinical examination evaluation, clinical monitoring and clinical writing with approval-compliant documentation to personnel development as also strategy, process and quality optimization.
Eight statutory clinical fields of action for the manufacturer - as Clinical Evaluator we take over or support the statutory clinical evaluation and documentation of the manufacturer as well as the clinical PMS.
Clinical development plan
Compliance with medical regulations and standards
Medical evaluation for recertification
Clinical reassessment of medical devices approved according to old regulations
Fields of action for manufacturers from 2019-2024
The challenges for you as a manufacturer of medical devices
With regard to the clinical evaluation, the further challenges facing medical device manufacturers are mainly due to the differences between EU Directive 93/42 and EU Regulation 2017/745 in six main areas:
The entire development of a medical device, marketing and sales can affect more than the legal requirements and other clinical issues and action areas. more...
Typical examples are
- entrepreneurial decisions on product idea, patenting and development start,
-Classification, preclinical testing or omission of a clinical evaluation as well as
- medical monitoring of risk management, conformity procedures or scrutiny procedures.
With additional challenges
- Distribution channels (eg reimbursement by the GKV) as to
- Business Management and
- Strategy of the company come.
Prof. Zenner's memberships
Medical Association Baden-Württemberg, Stuttgart
Bavarian Medical Association, Munich
N.Y. Academy of Sciences, New York
Académie Nationale de Médicine, Paris
National Academy of Sciences Leopoldina, Halle/Berlin