Who we are

Our background

Clinical, operative and experimental medicine, as well as engineering, business administration and pharmacy. Since 1996 specialist clinical evaluation / risk analysis of medical devices, own industry experience, own experiences in the product development and own experiences with clinical studies (see information column right).

Our services

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 Advice for Product Idea / Patenting / Preclinical Testing / Classification | Process / Structural Engineering | Personnel training | strategy development.

Senior Clinical Evaluator

Professor Hans-Peter Zenner, MD, MBA, Dr. med.

Partner Doctors´ Network

Practically all medical specialities are represented by medical specialists in our network of partner doctors. 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.

History

1988 foundation as an appraisal office

Medical device evaluation since 1996

Around 1500 consultations / assessments in German and English for around 500 clients v.a. in Germany, Switzerland, France, USA

Offices in Munich and in Tübingen / Stuttgart

Industrial experience

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.

Products and Development

We have our own experience in product development from surgical instruments to electronic diagnostic devices to implantable drug pumps and active neuroimplants.

Clinical Assessments

In addition, there are own experiences as examiners or LKP according to MPG / AIMDD.

Partner Network

Through Prof. Zenner and his partner network, practically all medical subjects are represented by specialists throughout Germany.