Regulatory Reporting Procedure

This procedure defines how your organisation notifies regulatory authorities of complaints and events that meet the reporting criteria of the applicable regulations, and how it issues advisory notices (field safety notices) and carries out field actions.

What's Inside

• Procedure — Adverse Event Reporting
• Identification of Potentially Reportable Events
• Reportability Assessment
• Reporting Timelines
• Preparation and Submission of Reports
• Investigation, Follow-up and Final Reports
• Periodic and Trend Reporting
• Closure of Vigilance Files

ISO 13485 Alignment

Supports ISO 13485:2016 requirements, including Clause 8.2.3. It fits with the rest of the QEHS Vault ISO 13485 document set.

Format

Supplied as a fully editable Microsoft Word (.docx) file. Add your organisation’s name, logo and details, then use it straight away. Instant download after purchase.