Advanced Quality System Solutions
 
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Verification and Validation Protocols

A well-written protocol includes the following information:

  • Sample size and justification for sample size

  • Acceptance criteria clearly defined

  • Steps to be taken in the case of test failures

  • Description of data analysis

  • Complete listing of equipment to be used

  • Training requirements for associates who will perform the testing



AdvQSS Client Serv ices

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

  • Quality system development and compliance
    • 21 CFR Part 820 (FDA)
    • EN ISO 13485:2003
    • Canadian Medical Devices Regulation (CMDCAS)
    • 93/42 EEC Medical Device Directive as amended by 2007/47
    • 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
  • Quality system audits and gap analyses 
  • 2nd party supplier audits
  • Technical documentation required for CE Marking
  • 510(k)s and Canadian medical device license applications
  • On-site training specific to client needs (CAPA, complaints, risk management, auditing, etc.)
 
Advanced Quality Systems Solutions
Everything should be made as simple as possible, but not one bit simpler.
Albert Einstein, (attributed), US (German-born) physicist (1879 - 1955)
Advanced Quality System Solutions

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ADVQSS is a full service consulting company founded by Michelle Johnston specializing in the medical device industry. Its’ goal is to offer clients timely, cost-effective solutions to quality system compliance issues.

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