Data Integrity Support for Medical Device and IVDs

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