Filter the references 315 reference(s) found

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DREEM

Manufacturer
Neurology, Psychiatry & Sleep
Compliance Quality
  • Implementation of ISO 13485:2016 and 21 CFR Part 820
  • CE Marking for a Headband That Measures Nighttime Brain Activity

CIDELEC

Manufacturer
Neurology, Psychiatry & Sleep
Regulatory monitoring
  • Monitors legal and regulatory requirements for the export of polygraphy and polysomnography devices

PPRS SomnoArt

Manufacturer
Neurology, Psychiatry & Sleep
Compliance
  • Reimbursement Application for a Device Used to Diagnose Sleep Disorders

BRAINDEX

Manufacturer
Neurology, Psychiatry & Sleep
Compliance Quality +1 prestation
  • CE Marking under Regulation 2017/745 for a medical device for anesthesia optimization

NUKLEUS

Manufacturer
Neurology, Psychiatry & Sleep
Compliance
  • Clinical Case Report on a Method for Measuring Colonic Transit Time Using RFID

HYPNO VR

Manufacturer
Neurology, Psychiatry & Sleep
Compliance Quality
  • Implementation of the ISO 13485:2016 Quality Management System
  • CE Marking for Virtual Reality Headset Used in Anesthetic Hypnosis

AXILUM ROBOTICS

Manufacturer
Neurology, Psychiatry & Sleep
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System
  • Placing a TMS Robot on the Market - CE, FDA, and Canadian Requirements

VITAREGUL

Manufacturer
Medical Software & AI (SaMD)
Compliance
  • CE Marking Technical File for Vigilance Data Recording Software

SITUP

Manufacturer
Rehabilitation, Mobility & Disability
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System
  • CE Marking Documentation for Motorized Medical Bed/Lift Chair

THREE BONUSES

Manufacturer
Medical Software & AI (SaMD)
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System
  • Technical File for CE Marking under Regulation 2017/745 for Concussion Detection Software

SATISFORM

Manufacturer
Rehabilitation, Mobility & Disability
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System
  • CE Marking for Biomechanical and Functional Rehabilitation Equipment

TERENUI

Manufacturer
Medical Software & AI (SaMD)
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System
  • Technical Specifications for Software to Manage the Care Pathways of Patients in the ICU