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Post-market surveillance

Consulting
Pricing/Discount Options: Call #2
Unique Identifier: 38934b75-773d-49fe-8a84-40f80940cce3

Service Description

To facilitate post-market surveillance implementation, as introduced by the MDR, this service offers pro-active information retrieval relevant to reported problems in medical devices by scanning and aggregating query results from official public databases of competent national authorities.

Keywords: Post market surveillance, Risk analysis, Pro-active market vigilance, MDR, Field safety notice, PSUR

Offerings: Business (market readiness, monitoring, feasibility, etc.) Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.)
TEF-Health Use Case Domain: all
Provider Logo

Provider & Contact

Provider Organisation Politecnico Di Milano (POLIMI)
Provider Country Italy
Published Email tef-health@polimi.it

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

Service Inputs Potential EMDN nomenclature of the considered product category, device name, manufacturer name
Service Outputs Report
Dependencies & Restrictions AI act; MDR
Certification Support Periodic Safety Update Report (PSUR)
  • PSUR
Service Standards EU Regulation 2017/745
  • EU Regulation 2017/745

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