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Regulatory Consulting: Elaboration or revision of PMSR and PSUR reports

Consulting
Pricing/Discount Options: Call #2 Call #1
Unique Identifier: cac66073-ae9e-4138-aafb-3fe3bdf556b7

Service Description

The placing of a medical device or an IVDon the market is preceded by an evaluation of the residual risks related to quality, safety and performance. However, this evaluation shall continue throughout the entire lifecycle of the device, including the post-market period. Post-market surveillance allows manufacturers to collect and analyze experiences of the actual use of medical devices. Based on the outcome of this analysis, further actions such as incident reporting to competent authorities, field safety corrective actions or safety warnings to users may be required. Post-market surveillance activities are planned in the Post-market Surveillance Plan and the data is compiled in the Post-marketing Surveillance Report - PMSR (for class I medical devices) or the Periodic Safety Update Report (for class IIa, IIb and III medical devices or class C or D IVDs). Our unit assists in the elaboration of the PMS Plan with the definition of actions and also the elaboration of PMSR or PSUR

Keywords: MDR Post-Market Surveillance (PMS) PSUR
Offerings: Ethics & Regulatory Affairs Quality Management Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.) Development of conformity evaluation standards, protocols & tools
TEF-Health Use Case Domain: all
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Provider & Contact

Provider Country Portugal
Published Email medicaldevices@ipn.pt

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

Operational Details

Certification Support CE Marking (MDR, IVDR)