Home References Page 14

The references of Isocèle Conseil

Filter the references 315 reference(s) found

Filter

Sectors

Typologies

Services

Remove all Display 315 results

CLIN EXPERTS

Manufacturer
Medical Software & AI (SaMD)
Compliance
  • Preparation of a Clinical Trial Dossier

Tours University Hospital

Other
Medical Software & AI (SaMD)
Training course
  • Implementation of the ISO 13485 Quality Management System for a decision-support software tool (PCC Project—Catheter Compatibility Prediction)

NANOBIOTIX

Manufacturer
Oncology
Audit
  • Internal Audit in Accordance with ISO 13485

TECHNOLOGY HIGHLIGHTS

Manufacturer
Medical Software & AI (SaMD)
Compliance Quality
  • Quality Assurance Implementation - ISO 9001 Certification, July 2000
  • CE Marking and FDA Approval

DAMAE Medical

Manufacturer
Oncology
Compliance Outsourced Quality Manager
  • Support for clinical trials of a device to aid in the diagnosis of skin cancers
  • CE Marking for a Device to Aid in the Diagnosis of Skin Cancers
  • Outsourced Quality Manager since 2018

CAP Gemini

Manufacturer
Medical Software & AI (SaMD)
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System
  • CE Marking for "Ange Gardien" Digital Public Health Tools

ZETA Technologies

Manufacturer
Neurology, Psychiatry & Sleep
Compliance
  • Regulatory Strategy for a Neurofeedback System for the Treatment of Tinnitus

BYOND

Manufacturer
Medical Software & AI (SaMD)
Compliance
  • Regulatory support for patient management software (clinical laboratory science)

CARTHERA

Manufacturer
Neurology, Psychiatry & Sleep
Compliance Quality
  • Preparation of the clinical dossier to optimize intracerebral bioavailability
  • Implementation of the ISO 13485 Quality Management System
  • CE Marking for Optimization of Intracerebral Bioavailability

SOMNO Engineering

Manufacturer
Neurology, Psychiatry & Sleep
Compliance Quality
  • Clinical Investigation Dossier
  • Implementation of the ISO 13485 Quality Management System
  • CE Marking for a Sleep Analyzer in the Intensive Care Unit

ERIDANIS

Manufacturer
Neurology, Psychiatry & Sleep
Compliance Training course
  • Training and Support for Software Integrated into a Class III Electromedical Device

SAMDOC

Manufacturer
Neurology, Psychiatry & Sleep
Compliance
  • Technical File for CE Marking under Regulation 2017/745 for Pain Analysis Software