Data Integrity Support for Medical Device and IVDs
Assess a wide range of regulatory requirements to identify areas of risk and support your internal or supplier audit programs.
Whether you are looking for an in-depth, expert assessment of a specific issue or to outsource your entire supplier audit program, NSF provides a range of assessments and audits. We also support FDA readiness and offer data integrity audits that help you identify areas of risk.
Our auditing and assessment services include:
- Gap assessments
- Mock FDA inspection and FDA readiness support
- Mock European regulatory agency audits
- Data integrity audits
- ISO 13485 and QSIT
- Compliance audits to EU MDR
- Supplier audits
- Due diligence assessments for large and small-scale acquisitions
