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Summative evaluation of surgical medical device

Physical
Pricing/Discount Options: Call #2
Unique Identifier: 2e647770-b234-47b7-b0c7-3f17de282c56

Service Description

Summative evaluation of finalized surgical robot prototype (design freeze) in order to validate usability (according to IEC 62366-1). This packaged service includes : - Operating room rental - Participants (healthcare professionals) recruitment within our hospital - Protocol elaboration - User testing organization and moderation - Analysis of collected data from a human factors perspective - Evaluation report including root causes analysis of errors, close calls and use difficulties observed Prices range is indicative and depends on testing protocol complexity and particpants number

Offerings: Testing Conformity & Compliance Hardware (CE, MDR, usability, etc.) Testing Facility Simulated (ER, OR, ICU, office, ambulance, ward, patient home, etc.)
TEF-Health Use Case Domain: all
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Provider & Contact

Provider Organisation Hospices Civils De Lyon (HCL)
Provider Country France
Published Email jean-francois.menudet@chu-lyon.fr
Billing: per evaluation
Full Price €28000-50000 EUR
Reduced Price €22000-44000 EUR
Pricing Detail

Price will be calculated according to the study complexity and the involved staff. A 50% discount is available for employees funded by the TEF Health project

Operational Details

Service Inputs Product to evaluate + finalized use-related risk analysis
Service Outputs Summative evaluation report
Certification Support IEC 62366-1
  • IEC 62366-1
Service Standards IEC 62366-1
  • IEC 62366-1

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