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As a scientific expert, I advise and support medical device manufacturers at the cross-section between innovation, clinical or biological product evaluation and CE marking – the whole process from the product idea to the market-ready medical device.


Dr. Micha Feld

SCIENTIFIC & REGULATORY EXPERT


TOP SKILLS: Clinical Evaluation, SSCP, SOPs for Technical Documentation


Why PRO-LIANCE
Medical devices save lives! This may sound dramatic – but it's true. On a daily basis, countless innovations strengthen the impact of medical technology on our lives. As a result, the continuous optimization of medical technology solutions ensures that the products can be tailored specifically to the demands of their respective indication areas, with the aim of improving their applicability and/or maximizing therapeutic success.

Challenges
However, innovation is not everything. Medical devices must also be safe and efficient. Therefore, it is essential for medical devices to be designed in accordance with all applicable regulations. Welcome to the age of Regulation (EU) 2017/745.

My strengths
As an expert for clinical evaluations, I advise and support medical device manufacturers at the crossroads between innovation, clinical/biological product evaluation and CE marking- the entire range from the product idea to the market-ready medical device. Over the course of my activities in the biotech and medical device industry, I have continuously refined my expertise in the fields of dermatology, oncology, surgery, intensive care medicine and dentistry.

My motivation
As a biologist with a PhD and many years of experience in research and development of new therapeutic approaches in the fields of virology and oncology, medical and technical innovations are particularly close to my heart.

Who I am
I have been passionate about dermatology for many decades. I regularly explore the medical and cosmetic market for promising therapeutic options and minimalist formulation approaches. In doing so, I also focus on the quality of the published scientific data, which is often already a clear indicator of the actual anticipated performance of the respective product. I am happy to exchange ideas with "real" dermatologists from my network and am always ready to participate in the development of new dermatological products in an advisory capacity.

Scientific & Regulatory Expert

PRO-LIANCE GLOBAL SOLUTIONS GmbH

Biotech Consultant

OncoLead

Project Manager Drug Discovery & Laboratory Head

Rigontec

Work group leader & Project Manager Allergy & Autoimmunity

University Hospital Münster

Laboratory Leader

University Hospital Münster

Postdoctoral Researcher

University Hospital Münster

Dr. rer. nat. (Biology)

Clinical Evaluation

SSCP

SOPs for TD

Regulatory consultancy targeting EU market access

Consultancy on regulatory compliance

Gap analysis

Definition and quantification of relevant medical device-specific benchmark parameter

Development of literature retrieval strategies

Project management

Languages: German, English