What We Do?
CDAQI research provides support in preparing high quality Periodic Safety Update Report to all our clients.
Periodic Safety Update Report is prepared as per EU Medical Device Regulation 2017/745 of Annex III requirements.
A Periodic Safety Update Report summarizes the results and conclusion of the analysis of the Post-Market Surveillance data gathered as a result of the Post-Market Surveillance Plan.
Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety update report (‘PSUR’) for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan with a rationale and description of any preventive and corrective actions taken. Throughout the lifetime of the device concerned, that PSUR shall set out:
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PSUR should include the following:
- Your postmarket surveillance data
- The conclusions of your benefit-risk analysis
- A description of any CAPAs and the rationale behind them
- The findings of your Post Market Clinical Follow-up
- The device’s sales volume and an estimate of the user population
- The frequency of the device’s usage (if practical)
- An analysis and summary of all the information listed above
