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Usability: Summative evaluation of medical device

Physical
Pricing/Discount Options: Call #2
Unique Identifier: a204b41f-054c-4cfb-a99c-d633a0929b48

Service Description

Summative evaluation of medical devices: final user testing of any medical device in order to carry out the final summative evaluation needed for CE mark (according to IEC 62366-1). It includes: - writing the protocol - recruitment of required healthcare professionals and patients - rental of the operating room if needed - rental of phantoms - user testing according the defined protocol and result analyses - evaluation report.

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 Logo

Provider & Contact

Provider Organisation Centre Hospitalier Universitaire De Grenoble (CHUGA)
Provider Country France
Published Email tef-health@chu-grenoble.fr
Billing: per evaluation
Full Price €8000EUR to 30000EUR
Reduced Price €5000-25000 EUR
Pricing Detail

Prices are subject to change and are indicative only. The final price will be determined by a quote based on SME's needs, and it wil be validated by the contract between the service provider and the applicant.

Operational Details

Service Standards IEC 62366-1
  • IEC 62366-1

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