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WANDERCRAFT

Manufacturer
Rehabilitation, Mobility & Disability
Audit
  • ISO 13485 Quality System Audit for a Manufacturer of Leg Exoskeletons

TECHNICA NATURALIS

Manufacturer
Rehabilitation, Mobility & Disability
Compliance
  • Regulatory Strategy for Movement-Assistive Exoskeletons

SMD

Manufacturer
Rehabilitation, Mobility & Disability
Compliance
  • CE Marking in accordance with Regulation 2017/745 for medical devices used in aquatic rehabilitation

SKEEWAI

Manufacturer
Rehabilitation, Mobility & Disability
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System
  • CE Marking Technical File for TMS Coverage Application

BIOXIS

Manufacturer
Gynaecology, Obstetrics & Perineum
Audit Compliance
  • Compliance with Regulation 2017/745 for Class III implantable devices based on hyaluronic acid
  • ISO 13485 Internal Audit

TINTEO

Manufacturer
ENT, Hearing & Tinnitus
Compliance Quality
  • ISO 13485 Quality Management System
  • CE Marking for a Hearing Aid and Tinnitus Measurement Software

STIMULI

Manufacturer
Gynaecology, Obstetrics & Perineum
Compliance
  • Support for CE Marking of an Electromedical Device for Tibial Nerve Stimulation

ROBIN GUILLARD

Manufacturer
ENT, Hearing & Tinnitus
Compliance
  • Regulatory Strategy for a Software Application to Assist in the Treatment of Tinnitus

MAYFAIR DEVELOPMENTS

Manufacturer
ENT, Hearing & Tinnitus
Compliance Quality
  • Implementation of the ISO 13485:2016 Quality Management System
  • CE Marking for a Device for Treating Tinnitus/Hyperacusis

CDD Laboratory

Manufacturer
Gynaecology, Obstetrics & Perineum
Compliance Quality +1 prestation
  • Quality System Monitoring
  • 510(k) Filing for Women's Medical Devices
  • Veille réglementaire

HEARING SPACE

Manufacturer
ENT, Hearing & Tinnitus
Compliance Quality
  • Regulatory support for hearing test software designed for hearing aid specialists

7Med Laboratory

Manufacturer
Gynaecology, Obstetrics & Perineum
Compliance
  • Identifying Changes That Must Be Reported to Health Canada and Handling Notifications for Intrauterine Devices