Medical Affairs, Clinical Affairs and Regulatory Affairs Specialist

Experienced in Clinical Pharma Affairs, Medical Devices and IVDs (Production, OEM, Clinical Studies, Market Authorization worldwide).

• Clinical Research
• Clinical Study Management
• Good clinical practice (GCP)
• Market Access
• Medical Writing
• Medizin
• Pharmazie
• Regulatory Affairs Management

I have been a clinical health care professional for more years than I like to admit to.  I have a reputation for a high engagement in all my projects. making potentially difficult subjects highly effective. I particularly love building systems and train people understand why GCP is so important and what it actually means in practice.
A little bit more about my background:
I am a medical doctor and began my career in clinical healthcare in 1993. After my medical degree 2001, I worked as a physician in interventional cardiology, electrophysiology and intensive care medicine in a maximum care clinic for 7 years before starting my own business in the medical device industry in 2008. I have designed and produced Class III medical laser-devices, done clinical research and built a fast growing OEM business for customers in the medical device- biotech- and pharma industry. The tasks for me and my team was to design, produce and validate products and prepare clinical First in Man and Pivotal Trials for an international market launch. My company was awarded several times among others as the world´s most innovative life-science company in 2013.
Founding VYSYO in 2016 was the logical next step and I switched to the consulting business for the Medical Device~, IVD~ and Pharmaceutical Industry. I work with Pharma and Biotech companies, CROs, Hospitals, Academic and Medical Institutions.
My customers appreciate the combination of my clinical- and industrial expertise. I have worked as a project leader for numerous international clinical trials covering both ICH and FDA requirements. Me and my team help to launch and maintain products in 47 countries, and we often can add value in terms of increased re-imbursement and decreased costs of evaluation documentation for medical and medicinal products and IVD.
I developed training courses for Clinical Research and re-imbursement strategies for IVD, Pharmaceutical and medical products and run certificaiton programmes for QM systems and clinical investigations - and speak at international clinical research conferences.
I also have a network of colleagues I can call upon to help deliver specific projects if we need additional resources.

Primary Areas of Expertise
Clinical Research
Clinical Evaluation
IVD performance evaluation & Scientific validity report (IVDR Art. 2 (44)) 
Clinical Studies for Medicinal Products
Clinical Trials for Medical Devices
Clinical Performance Studies for IVDs
Clinical Study Reports
AE/SAE monitoring and reporting during pre-market clinical investigation. 
Medical Monitoring and reporting in multi national trials. 
PMS - Post-market surveillance, vigilance and market surveillance (including MEDDEV 2.12-1 rev 8). 
PMCF - Post market clinical investigations, PMCF Studies (MEDDEV 2.12-2 rev 2, ISO 14155). 
MEDDEV 2.7/1 rev 4, ISO 14155, REGULATION (EU) No 536/2014, ICH Good Clinical Practice (GCP) E6 (R2), IVDR Art. 2 (44)
Re-imbursement strategies for Health Products including Negotiations with public and non-public health insurance companies
Marketing & Sales Planning.
International market authorization for medical devices, IVDs and Medicinal products