QMS Startup Pack - EU, UK and US

This provides a full starter pack for a Startup Medical Device organisation or any organisation who wants to review current standards and update their existing set. This set includes regulatory requirements for the EU, UK and the US. If you need support integrating this pack into your organisation, contact us.

Our experienced team can help you tailor these to your device and organisation, contact us at: www.stjohnlynch.com

This pack contains:

• Quality Manual
• Document Control SOP
• Records Management SOP
• Management Review SOP
• Training Competence SOP
• Infrastructure Equipment Calibration SOP
• Design & Development Control SOP
• Supplier Purchasing SOP
• Production Process Control SOP
• Non-Conforming Product SOP
• Complaints Feedback & Vigilance SOP
• Post-Market Surveillance SOP
• Internal Audit SOP
• CAPA SOP
• Risk Management SOP
• Labelling & Regulatory Marking SOP
• CAPA Record Template
• Design Plan Template
• Management Review Template
• Quality Agreement Template
• Regulatory Submission Readiness Work Instruction