Regulatory, Quality & Analytics Consultant in the Medical Device Industry

Seeking to drive digital transformation within MedTech. #DataDrivenStrategy

• Auditor
• Data Science
• DIN EN ISO 13485
• EN ISO 14971
• International registrations
• IVDR
• MDR
• PRRC
• QMB
• Risikomanagement

A. has a strong background in medical devices in
Regulatory Affairs and Quality Management.
He worked several years as head of QM/RA, PRRC
(MDR) and QM Rep. (EN ISO 13485).
He was the lead auditor in internal as well as supplier
audits.
A. has deep knowledge of
risk management and
medical device product life cycles. He also supported in
R&D projects to formulate a sound regulatory strategy.
He specializes in process optimization and
automation leveraging methods like Lean Six Sigma
and machine learning.
He was responsible for raising awareness and training
company employees in both quality and regulatory
matters