About ADVQSS     |    Our Services     |    Industry Info     |    Request info
 

2008 MD&M East presentation

Who is Minding the Standards - by Michelle Johnston

Powerpoint, click to play. 
Choose 'open' when prompted.



ADVQSS will work with you to address all of your needs including the following:

  • Quality system development and compliance
    • 21 CFR Part 820 (FDA)
    • Canadian Medical Devices Regulation
    • 93/42 EEC Medical Device Directive
    • 98/79/EEC, In-Vitro Diagnostic Directive
    • 90/385/EEC, Active Implantable Medical Devices Directive
    • Japan PAL (Pharmaceutical Affairs Law)
  • Improvements to existing quality systems
  • FDA Warning Letters and 483 responses
  • Adverse event reporting and product recalls
  • 3rd party Notified Body/quality system registrar corrective action plans
  • Internal audits
  • 2nd party supplier audits
  • Technical documentation required for CE Marking
  • On-site training specific to client needs (CAPA, complaints, risk management, auditing, etc.)

 

 
Everything should be made as simple as possible, but not one bit simpler.
Albert Einstein, (attributed), US (German-born) physicist (1879 - 1955)

Home      |      About Advanced Quality System Solutions      |      Our Services      |      Industry Info      |       Request Info      |      Contact Us
More Links
Advanced Quality System Solutiions is a full service consulting company founded by Michelle Johnston specializing in the medical device industry.  New quality system development or solutions to existing compliance issues—FDA QSR, ISO 13485, 93/42 EEC, Canadian Medical Device Regulation. 

© Copyright 2008 ADVQSS.  All rights reserved.                                                                 Site by DWM