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The references of Isocèle Conseil

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PHYSIDIA

Manufacturer
Diabetes, Dialysis & Metabolic Disorders
Audit
  • Internal audit for a manufacturer of Class IIb hemodialysis devices

KITECH

Manufacturer
Diabetes, Dialysis & Metabolic Disorders
Compliance
  • Regulatory Strategy
  • Technical Specifications for a Monitoring Device for Dialysis Patients

NORMANDIE ENDO TECHNOLOGY

Manufacturer
Mini-invasive surgery, Endoscopy & Robotics
Compliance Outsourced Quality Manager +1 prestation
  • ISO 13485 QMS Monitoring
  • Technical Files for CE Marking
  • Outsourced Quality Manager Role

IMPETO MEDICAL

Manufacturer
Diabetes, Dialysis & Metabolic Disorders
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System
  • CE Marking and 510(k) Filing
  • Client we have been working with since 2010

MEDLANE

Distributor
Mini-invasive surgery, Endoscopy & Robotics
Compliance Quality +1 prestation
  • Training on Directive 93/42/EEC
  • ISO 13485 QMS Upgrade
  • CE Marking for Surgical Instruments

ISIS-STRAS

Manufacturer
Mini-invasive surgery, Endoscopy & Robotics
Compliance
  • Support for the development of the design documentation for a flexible endoscopic platform

CONECTLABS

Manufacturer
Mini-invasive surgery, Endoscopy & Robotics
Compliance
  • Regulatory Compliance of a Robotic Prototype

FRIENDS

Manufacturer
Mini-invasive surgery, Endoscopy & Robotics
Compliance Quality
  • Implementation of the ISO 13485:2016 Quality Management System
  • CE Marking Technical Files for Endoscopy Devices

SAFEHEAL

Manufacturer
Mini-invasive surgery, Endoscopy & Robotics
Quality
  • ISO 13485 Quality Management System for a Solution to Reduce Anastomotic Complications During Colectomies

PROTOMED

Manufacturer
Mini-invasive surgery, Endoscopy & Robotics
Audit
  • Internal Audits for Manufacturers of Non-Active, Sterile, and Non-Sterile Surgical Instruments

YNNOV

Manufacturer
Rehabilitation, Mobility & Disability
Compliance
  • Regulatory Strategy for a 3D Spinal Functional Analysis Device with Feedback

WENS

Manufacturer
Rehabilitation, Mobility & Disability
Compliance
  • Technical File for CE Marking of Finger Sensitivity Rehabilitation Gloves