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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

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 Standards IEC 62366-1
  • IEC 62366-1

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