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The references of Isocèle Conseil

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Earpiece Manufacturers

Manufacturer
ENT, Hearing & Tinnitus
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System
  • Support for 5 manufacturers in achieving compliance with Regulation 2017/745—Custom-made devices

FIZIMED

Manufacturer
Gynaecology, Obstetrics & Perineum
Compliance Quality
  • QMS Monitoring
  • CE Marking for the EMY Perineal Rehabilitation Device

PLASANA

Manufacturer
Dermatology, Aesthetics & Skincare
Compliance
  • Clinical Trial Protocol for a Device for the Treatment of Chronic Wounds

HEAR

Manufacturer
ENT, Hearing & Tinnitus
Compliance
  • Preparation of the Technical Dossier - Custom-Made Medical Device

NOVELSKIN

Distributor
Dermatology, Aesthetics & Skincare
Quality
  • Implementation of the ISO 13485 Quality Management System for a distributor of medical devices and cosmetics

MARCO POLO LIVE

Manufacturer
Dermatology, Aesthetics & Skincare
Compliance Quality
  • Resumption of the QMS and ISO 13485 Compliance
  • CE Marking under OBL Procedures for Acupuncture Needles

MHW

Distributor
Dermatology, Aesthetics & Skincare
Compliance
  • CE Marking of a Radiofrequency Conductive Cream and Laser Conductive Gels

TRANSDERMA

Manufacturer
Dermatology, Aesthetics & Skincare
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System and CE Marking for an Ultrasonic Mesotherapy Device

TEOXANE Laboratories

Manufacturer
Dermatology, Aesthetics & Skincare
Audit
  • Production audit in accordance with customer requirements and ISO 9001/ISO 13485 (for LEADERM, a medical device manufacturer)

Group Text Message

Manufacturer
Dermatology, Aesthetics & Skincare
Audit Compliance
  • Quality and Regulatory Audit in Connection with the Acquisition of a Manufacturer of Tecatherapy Devices

E-SWIN

Manufacturer
Dermatology, Aesthetics & Skincare
Compliance Quality
  • Implementation of ISO 9001 and ISO 13485 Certifications
  • CE Marking for Hair Removal Flash Lamps

SYNTHEBIO

Manufacturer
Dermatology, Aesthetics & Skincare
Audit Compliance +1 prestation
  • QMS Audit Prior to ISO 13485 Certification
  • Annual QMS Follow-Up for an Ultrasonic Adipocyte Removal Device