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The references of Isocèle Conseil

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RESILIENT Innovation

Manufacturer
Rehabilitation, Mobility & Disability
Compliance
  • Assessment and Regulatory Strategy for a Device to Assist People with Gait Disorders

REEV

Manufacturer
Rehabilitation, Mobility & Disability
Compliance Quality
  • Implementation of the EN ISO 13485:2016 Quality Management System
  • Technical File for CE Marking of Exoskeletons and Digital Rehabilitation Solutions

Sapiens Bioscience

Manufacturer
Medical Software & AI (SaMD)
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System
  • CE Marking under Regulation 2017/745 for Medical Diagnostic AI/Tumor Markers

PROCOMEDIC

Manufacturer
Rehabilitation, Mobility & Disability
Compliance Quality
  • CE Marking and Quality Management System for a Distributor of Rehabilitation and Physical Therapy Equipment

PREDILIFE

Manufacturer
Medical Software & AI (SaMD)
Compliance Quality
  • CE Marking for Breast Cancer Prediction Software
  • 510(k) Application for Breast Cancer Prediction Software

OMNI

Manufacturer
Rehabilitation, Mobility & Disability
Compliance Quality
  • Implementation of a Quality Management System
  • CE Marking Documentation for a Mounting System That Allows a Wheelchair to Be Used as a Scooter

H’ability

Manufacturer
Rehabilitation, Mobility & Disability
Compliance
  • Technical Specifications for a Virtual Reality Software Solution for Upper Limb Functional Rehabilitation

GYROLIFT

Manufacturer
Rehabilitation, Mobility & Disability
Quality
  • Implementation of an ISO 13485 Quality Management System for a Class 1 medical device based on Segway technology/seated robotics

MADUP

Manufacturer
Rehabilitation, Mobility & Disability
Compliance
  • CE Marking of a Physical Training Device

KOMUNITY

Manufacturer
Rehabilitation, Mobility & Disability
Compliance
  • Technical File for CE Marking of External Textile Breast Prostheses

GEMA Life

Manufacturer
Rehabilitation, Mobility & Disability
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System
  • Technical File for CE Marking of a Standing and Walking Aid for the Elderly

INVACARE

Manufacturer
Rehabilitation, Mobility & Disability
Audit
  • Conducting ISO 13485 audits for a manufacturer of medical chairs and beds