Quality Management System

To facilitate early recognition of diseases, correct diagnosis, and efficient treatment with world-class medical-technical solutions.

Our quality philosophy

The main and essential goal of Our Company is  to achieve the complete medical-pathological process, and thereby elaborating and realising new diagnostic methods. In the course of research and development, the created methods and assets must consistently meet the applicable advanced-level quality requirements that effectively facilitate medical-diagnostic processes, therefore achieving effective treatment of patients.

We realise our objectives through consequent validation of the following fundamental values:

  •     proactive thinking in product development
  •     continuous innovation in hardware and software development
  •     flexible organizational structure and project management
  •     well-prepared professionals capable of working on their own initiative
  •     stable, mutually beneficial customer and supplier contacts
  •     well-established working conditions and working environment
  •     continuously developing, modern IT environment
  •     effectively protected knowledge-base and intellectual property             

 

Certifications:

ISO 13485 (PDF, EN)

ISO 13485 CMDCAS Canada (PDF, EN)

ISO 9001 (PDF, EN)

ISO 9001 (PDF, HUN)

 

Here you can find the list of our product certificates.
For more information please contact info@3dhistech.com

Pannoramic Digital Slide Scanners

Canadian Medical Device License (PDF, EN-FR)

Registration certificate for medical device, Peoples Republic of China
医疗器械注册证 , 中华人民共和国 (PDF, EN-CN)

Pannoramic 250 Flash II

IVD certificate issued to Pannoramic 250 Flash (PDF, EN)

Pannoramic 250 Flash CB (PDF, EN)

Pannoramic 250 Flash CB USA/Canada (PDF, EN)

Pannoramic 250 Flash EMC (PDF, EN)

Free sales certificate of Pannoramic P250 Flash (PDF, EN)

Pannoramic SCAN

IVD certificate issued to Pannoramic SCAN (PDF, EN)

Pannoramic SCAN CB (PDF, EN)

Pannoramic SCAN EMC (PDF, EN)

Free sales certificate of Pannoramic SCAN, MIDI and DESK (PDF, EN)

Pannoramic MIDI

IVD certificate issued to Pannoramic MIDI (PDF, EN)

Pannoramic MIDI CB (PDF, EN)

Pannoramic MIDI EMC (PDF, EN)

Free sales certificate of Pannoramic SCAN, MIDI and DESK (PDF, EN)

Pannoramic DESK

IVD certificate issued to Pannoramic DESK (PDF, EN)

Pannoramic DESK CB (PDF, EN)

Pannoramic DESK EMC (PDF, EN)

Free sales certificate of Pannoramic SCAN, MIDI and DESK (PDF, EN)

Pannoramic Confocal

Pannoramic Confocal Laboratory equipment

Pannoramic Confocal (IEC 61010-1:2010 - LVD)

Pannoramic Confocal (IEC 61010-1:2001 - LVD)

Pannoramic Confocal (EMC)

TMA Grand Master

Declaration of Conformity issued to TMA Grand Master (PDF, EN)

TMA Grand Master CB (PDF, EN)

TMA Grand Master EMC (PDF, EN)

TMA Master

Declaration of Conformity issued to TMA Master (PDF, EN)

TMA Master CB (PDF, EN)

TMA Master EMC (PDF, EN)

Pannoramic Viewer

Canadian Medical Device License for Pannoramic Viewer (PDF, EN-FR)

IVD certificate issued to Pannoramic Viewer (PDF, EN)

Free sales certificate of Pannoramic Viewer (PDF, EN)

MembraneQuant module

IVD certificate issued to MembraneQuant (PDF, EN)

Free sales certificate of MembraneQuant (PDF, EN)

NuclearQuant module

IVD certificate issued to NucleareQuant (PDF, EN)

Free sales certificate of NuclearQuant (PDF, EN)

FISHQuant module

Declaration of Conformity FISHQuant (EN, PDF)

Free sales certificate of FISHQuant (PDF, EN)

IVD certificate issued to FISHQuant (PDF, HU-EN)