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.)