Our company consists of highly skilled consultants who bring their many years of professional experience working with the FDA (U.S. Food and Drug Administration) and European regulatory authorities in securing regulatory compliance for medical devices.
- 25 years experience working with the FDA
- 25 years of practice with GxP audits, implementations and training
- Proven track record of medical device approvals
- Special expertise in process and software validation
- Implementation of cost-effective solutions with proven results
- Manufacturers of medical devices, IVD's and medical software
- Small and midsize businesses
- International corporations
The names of our clients are confidential and will not be disclosed. A list of our projects will be provided upon request.