Auditing Services

We are certified auditors and have extensive industry experience regarding:

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• Medical Device Single Audit Program - MDSAP

• 21 CFR Part 4 / 211 / 820

• ISO 13485 and ISO 9001

• European Device Medical Regulation (MDR)

• European IVDR

• Standards / Auditor Training

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

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• Medical Device Single Audit Program (MDSAP)

• Certification Audits

• Internal Audits

• Supplier Audits

• Mock FDA Inspections

• Product/Process Audits

• System Audits

• Desktop Audits

• Contract Audits

• Due Diligence

• Quality System Inspection Technique (QSIT)