Glass Buildings

Gap, Supplier Qualification, Internal, and Precertification Audits

How Can We Assist You?

Auditing Services

We are certified auditors and have extensive industry experience regarding:

  • ​Medical Device Single Audit Program (MDSAP)

  • 21 CFR Part 820 / 4

  • ISO 13485 and ISO 9001

  • European Device Medical Regulation (MDR)

  • European IVDR

  • Standards / Auditor Training

Our team will provide an unbiased, thorough evaluation and have extensive experience with the following types of audits:

  • Medical Device Single Audit Program

  • Certification Audits

  • Internal Audits

  • Supplier Audits

  • Mock FDA Inspections

  • Product/Process Audits

  • Desktop Audits

  • Due Diligence

  • Quality System Inspection Technique (QSIT)

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