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Technical-File-Template-Medical-Device

PSUR Template

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PSUR-Template

Price: $600

This template intended for class IIa, IIb and class III devices provides a comprehensive analysis of the post-market surveillance (PMS) data associated with the device. It enables the identification of any potential changes, including evidence of adverse events, to the benefit/risk profile of the device. It considers new or emerging information within the context of cumulative data on benefits and risks. It is prepared in strict accordance with Regulation (EU) 2017/745 – Article 83, 84, 86, Section 1.1 of Annex III, ISO/TR 20416:2020, NB-MED-2_12-1_rec1, MDCG 2022-21, MEDDEV 2.12.1 rev. 8, and MDCG 2023-3.

The analysis encompasses a thorough examination of PMS data, including adverse event reports, complaints, and other relevant sources of information. It aims to identify trends and potential issues that may impact the benefit/risk profile of the device. By providing a structured analysis of PMS data, this report enables manufacturers to address any emerging concerns, enhance patient safety, and maintain compliance with regulatory requirements.

This template is designed by highly experienced professionals for all medical device companies. Click below to get a preview of this template.

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