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NO MONKEY Business

Manufacturer
Dentistry & Dental Implants
Compliance
  • Regulatory Review of Training Software for Orthodontic Diagnosis and Aligner Treatment

HENRY SCHEIN

Distributor
Dentistry & Dental Implants
Compliance Training course
  • Training on Legal and Regulatory Requirements for Medical Devices
  • Review of Compliance for Products Imported in 2019

FLAMARC SDC

Manufacturer
Dentistry & Dental Implants
Compliance
  • Takeover of a CE Marking Technical File for a Manufacturer of Dental Alloys

NEODENT

Distributor
Dentistry & Dental Implants
Compliance Quality
  • Revision of the ISO 13485 Quality Management System
  • Bringing CE Marking Technical Files into Compliance

EMOSIS Concept

Manufacturer
Dentistry & Dental Implants
Compliance
  • Regulatory Support for Designers, Manufacturers, and Distributors of Dental Device Components

AVALUN

Manufacturer
In vitro diagnosis
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System
  • CE Marking Support for DMDIV

EMAIA

Manufacturer
Dentistry & Dental Implants
Compliance
  • Regulatory Strategy for Dental Healing Screws

ABODIAG

Manufacturer
In vitro diagnosis
Audit Compliance
  • Regulatory audit for CE marking of a pre-transfusion screening device

DENTOSMILE

Manufacturer
Dentistry & Dental Implants
Quality
  • Implementation of the ISO 13485:2016 Quality Management System for Custom Dental Trays

MAUNA KEA Technologies

Manufacturer
Medical Imaging & Radiology
Compliance Quality
  • Implementation of ISO 9001 and ISO 13485 Quality Management Systems for Optoelectronic Diagnostic Devices

HISTOSONICS

Manufacturer
Medical Imaging & Radiology
Compliance
  • Clinical Trial Support
  • CE Marking for a Robotic Sonic Therapy System (RAST/Histotripsy)

DENTALBIOME

Manufacturer
Dentistry & Dental Implants
Compliance
  • Strategic and Regulatory Assessment
  • CE Marking Documentation for a Custom Dental Workstation