With over 20 years of medical device experience of successfully implementing and assessing Quality Systems, interfacing with the FDA and interfacing with Notified Bodies, our goal is to provide the tools and experience you need to achieve regulatory compliance in the design, manufacture and distribution of medical devices.
We specialize in:
- Implementing and Assessing Quality Systems
- Performing Quality System Audits
- Performing Good Clinical Practice Audits of Sponsors, Sites,
CROs and Electronic Data Systems
- Audit Clinical Studies and Protocols
- Assisting with Due Diligence Audits
- Ascertaining surviving an FDA inspection via Mock Inspection
- Providing effective Training Programs in cGMP, ISO, GCP, FDA Quality System Inspections and BIMO Inspections
Let us facilitate your company’s success in meeting the regulatory requirements for:
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FDAs Quality System Regulation
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ISO 13485:2003
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Medical Device Directive
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Canadian Medical Device Regulations
-
Good Clinical Practices, ICH E6 GCP
- ISO 14971
- 21 CFR Part 11
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