Filter the references 315 reference(s) found

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BALIO Diagnostics

Distributor
In vitro diagnosis
Audit
  • ISO 13485 Quality System Audit for a Distributor of DMDIV Hematology/Biochemistry/Electrolyte Products

ECHOPEN Factory

Manufacturer
Medical Imaging & Radiology
Audit Compliance
  • Quality System Audit and Regulatory Strategy

SERPHYDOSIS

Manufacturer
Medical Imaging & Radiology
Compliance Quality
  • ISO 13485 Certification Support
  • CE Marking: Software Tool for Dose Traceability in Medical Imaging

VERMON

Manufacturer
Medical Imaging & Radiology
Audit Compliance
  • Support for the development of a new probe
  • ISO 13485 Internal Audit for Ultrasonic Transducers

TRIBUN Healthcare

Manufacturer
Medical Imaging & Radiology
Compliance Outsourced Quality Manager +2 services
  • Support for CE Marking and FDA Accreditation for DIV Imaging
  • Annual QMS Review
  • Veille réglementaire

THERAPANACEA

Manufacturer
Medical Imaging & Radiology
Compliance
  • CE Marking for AI Software Applications for the Care of Cancer Patients

RESOLVE STROKE

Manufacturer
Medical Imaging & Radiology
Quality
  • Implementation of an ISO 13485 Quality Management System for Ultrasound Imaging Devices

SUPERSONIC IMAGINE

Manufacturer
Medical Imaging & Radiology
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System and 21 CFR Part 820
  • CE Marking and FDA Approval for Ultrasound Imaging

DOSISOFT

Manufacturer
Medical Imaging & Radiology
Compliance Quality
  • Implementation of ISO 9001 and ISO 13485 Quality Management Systems
  • CE Marking - FDA Approval - TÜV Certification

OLEA MEDICAL

Manufacturer
Medical Imaging & Radiology
Audit Compliance
  • Mock Audit for ISO 13485 Certification and CE Marking of Software

ECM

Manufacturer
Medical Imaging & Radiology
Compliance Quality
  • Implementation of ISO 9001 and ISO 13485 Quality Management Systems
  • CE Marking for Ultrasound Machines

NUREA

Manufacturer
Medical Imaging & Radiology
Audit
  • Quality System Audit for Medical Image Analysis Software