Formative evaluation of surgical medical device
Service Description
Formative evaluation of surgical robot prototype (under development) in order to improve 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 design improvement recommendations and potential new use-related risks to mitigate 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
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
€8000-20000 EUR
Reduced Price
€5000-16000 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
Prototype to evaluate + if possible preliminary use-related risk analysis
Service Outputs
Formative evluation report
Certification Support
IEC 62366-1
- IEC 62366-1
Service Standards
IEC 62366-1
- IEC 62366-1