MDSAP Auditing Services

Gap, Supplier Qualification, Internal, and Precertification Audits

Auditing Services

Certified Medical Device Auditors  With Extensive Industry Experience Regarding:

  • ​Medical Device Single Audit Program (MDSAP)

  • 21 CFR Part 820 / 210 / 211 / 4

  • ISO 13485 and ISO 9001

  • European Medical Device Regulation (MDR)

  • European IVDR

  • Standards / Auditor Training

Our medical device consultants 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)

Help From Start to Finish

To achieve milestones effectively, you need medical device consulting services at several checkpoints along the process. By hiring us you’ll save precious time and money along the way.