Post-market surveillance
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 & Contact
Provider Organisation
Politecnico Di Milano (POLIMI)
Provider Country
Italy
Published Email
tef-health@polimi.it
Billing: per hour
Full Price
€67-160 EUR
Reduced Price
€49-117 EUR
Pricing Detail
Depending on the required expertise and the complexity of the request, rates range based on expert seniority. Prices are subject to change and are indicative only. The final price will be determined in the contract between the service provider and the applicant.
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