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
- 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
- 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.