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Welcome to Advanced Quality System Solutions (ADVQSS)

The website is currently being updated.

Please contact Michelle Johnston for your consulting needs:

  • Quality system audits (delivered more than 1600 days)
  • Quality system implementation/improvement
    -21 CFR Part 820
    -93/42 EEC
    -ISO 13485:2016
  • MDSAP (Medical Device Single Audit Program for US, Canada, Brazil, Australia, and Japan) gap analysis/implementation/audit
  • EU MDR 2017/245 gap analysis/implementation/audit (May 2020 is approaching!)
  • Supplier audits
  • On site quality system training

General Info:

  • ADVQSS was founded in 2007. Clients range from one-person company to Fortune 500 companies.
  • M. Johnston’s credentials:
    • 25 years in the medical device industry including QA/RA management. Previously employed by C.R. Bard, Kirschner Medical (Biomet), Ortho Development Corporation, Genzyme Corporation, Medical Device Consultants Inc.
    • Former full-time assessor with BSI (QMS registrar/Notified Body). Current part-time subcontractor, trained on EU regulations and MDSAP.
  • ADVQSS has a 100% success rate for client stage 2 certification audits (registrar issues certificate)
  • ADVQSS provides a cost-effective and practical approach to quality system compliance.

mjohnston@advqss.com or 858.722.4471