Quality Management

An established and documented Quality Management System (QMS) is critical for any business that has customers, no matter who those customers are.  The basis of any QMS is to prove that you are meeting, and in some cases, exceeding, customer requirements.


Our experienced staff can assist you with building and/or fine-tuning your QMS in a variety of ways.

Our Quality Services

  • Establishment of QMS; key processes and documentation
  • Internal Audits and Gap Analyses
  • ISO Standards compliance (ISO 9001, 13485, 14971, 27001)
  • FDA QSR (21 CFR 820) Compliance
  • MDR/IVDR Compliance
  • MDSAP Compliance

Our consultants have years of experience in Quality Management and auditing of various systems. Our consultants have numerous certifications in internal and lead auditor training, specializing in ISO 9001, ISO 13485 and MDSAP.

Contact us to find out more about our Quality Management Services