Our expertise

Competence

Clinical evaluation

Since 1996 specialist clinical evaluation / risk analysis of medical devices.

What we can do to help meet regulatory requirements for medical devices:

Clinical evaluation (CE: Clinical Evaluation) acc. EU-MDR / MDD / AIMDD / MPG | Preparation and clinical evaluation of clinical trials according to EN ISO 14155 / MPG / MPKPV | Gap analysis | Clinical Writing / Document Creation acc. EU-MDR / MDD / AIMDD / MPG / MEDDEV 2.7-1 Rev. 4 | Scrutiny / CEAR / MDCG | Clinical Post Market Surveillance according to EU-MDR Annex XIV Part B | Recertification |

Clinical Evaluation & More - we can do that beyond:

Since 1996, we have been a proven clinical industry partner, from idea assessment to clinical writing for patenting to clinical documents for CE approval, all the way to active neuroimplantation. Specifically, these are: Clinical Advice for Product Idea / Patenting / Preclinical Testing / Classification | Process / Structural Engineering | Personnel training | strategy development

Experience in product development and as a CSD

In addition, there are own experiences in product development (from surgical instruments to electronic diagnostic devices to implantable drug pumps and active neuroimplants) as well as examiners or CSD according to MPG / AIMDD.

Persons

Senior Clinical Evaluator
Prof. Dr. med. H.P. Zenner: learn more about his Expertise ...

Clinical Evaluators: breites Kompetenzportefolio im Facharzt- und Expertennetzwerk
Through Prof. Zenner and his partner network, practically all medical subjects are represented by specialists throughout Germany. In addition, there are partners with a university degree in engineering, pharmacy and business management. This helps us to a broad, if necessary. transdisciplinary portfolio of competencies in clinical-conservative and -operative activity with medical devices, in R & D, in analytics, diagnostics, scientific research and clinical research and in the management of the resulting, increasing knowledge. Some of the specialists are among the world leaders in their field with national and international appeal.