Who we are
pfm medical expert is a subsidiary of pfm medical ag, an internationally active, medium-sized family business with its headquarters in Cologne. For more than 50 years, pfmmedical has been successful in the development, manufacture and distribution of high-quality medical products and offers reliable services.
Born from the Regulatory Affairs Team of pfm medical ag, pfm medical expert offers its extensive expertise to companies in the medical technology sector.
Katja Klein, Management
- 30 years of experience in the medical device and pharmaceutical industry
- Training as International Regulatory Affairs Manager
- Project support in clinical trials with medical devices
- Medical writing
- Monitoring of clinical studies with the support of a well-established team
- Review of your technical documentation according to MDR
- Support with CE certification of your medical devices
Horst Gebhard, Management
- Support in the development and implementation of quality management systems in accordance with DIN EN ISO 13485:2016, the MDR, as well as the "Code of Federal Regulations - Title 21" of the FDA
- 35 years of experience in the medical device industry
- Auditor according to DIN EN ISO 13485 with focus on quality management and active medical devices
- Process development, process design