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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
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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.)
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