Regulatory Reporting Record
Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements.
- Standard
- ISO 13485
- Document Type
- Records
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Medical Devices, Records
This record documents decisions on, and submissions of, reports to regulatory authorities. ISO 13485:2016 clause 8.2.3 requires that, if applicable regulatory requirements call for notification of complaints that meet specified reporting criteria for adverse events or issuance of advisory notices, your organisation documents procedures for notifying the appropriate authority, and maintains records of reporting.
What's Inside
- Reporting Requirements Applied
- PART A — Adverse Event Report RR-27-001
- Event
- Reportability Assessment
- Submissions
- Investigation Summary (Final Report)
- Actions
- PART C — Advisory Notices and Field Safety Corrective Actions
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clauses 7.2.3, 8.2.3 and 8.3.3. 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.
Key Benefits
- Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements
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