Periodic Safety Update Report (PSUR) Procedure
- ISO 13485:2016 Complaint
- MDR (EU) 2017/745 Compliant
- MS Word Format
- Digital Content - Instant Download
Periodic Safety Update Report (PSUR) ProcedureThe Periodic Safety Update Report (PSUR) Procedure provides detailed guidance on the required structure and content of Periodic Safety Update Report (PSUR) for Class IIa, Class IIb, and Class III medical devices.
Periodic Safety Update Report (PSUR) Procedure - OverviewThe PSUR procedure notes all required sections of a Periodic Safety Update Report and provides detailed instruction to guide the user to properly address each PSUR section.
The PSUR procedure covers every report element such as; risk-benefit determination, signal and risk evaluation, clinical trial summaries and findings, summary tabulations and more. Periodic Safety Update Report (PSUR) Procedure - ComplianceThe Periodic Safety Update Report (PSUR) Procedure is ISO 13485:2016 and MDR (EU) 2017/745 compliant.
For more information about our Periodic Safety Update Report Procedure contact us at info@aplyon.com
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