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Operating Room - Clinical investigation

Physical
Pricing/Discount Options: Call #2
Unique Identifier: 1ee66425-ed2c-4822-b56b-2e74cc7aef91

Service Description

Conduct an interventional clinical study within clinical research facility CEA-Clinatec : Operating room and hospitalisation room, with access to Grenoble-Alpes University Hospital's network of clinicians. Clinical and regulatory support to set up and submit the clinical study within French regulatory framework.

Operating room equipped with: - Neuro navigation robotic system ROSA - Intraoperative 1,5T MRI (Espree, Siemens): positioned on a rail to go into the operating room during surgery - Mobile X-ray unit (general Electric) - Stereotaxis interventional radiography chain (Apelem)

Keywords: operating room; clinical study; surgery; neurology; medical device validation

Offerings: Testing Facility Real-World (ER, OR, ICU, office, ambulance, ward, patient home, etc.)
TEF-Health Use Case Domain: all
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Provider & Contact

Provider Country France
Published Email Abdelmadjid.HIHI@cea.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 Inputs Medical device to evaluate
Service Outputs Clinical Investigation/Evaluation report
Certification Support Medical Device Regulation ; ISO 14155:2020
  • ISO 14155
  • MDR
Service Standards Clinical research center: GCP, ISO 9001
  • Clinical research center: GCP
  • ISO 9001