Class I, II and III Devices

HELICON MEDICAL

Quality System

 

  • Complete customized quality system
  • implemetation of ISO 9001 and ISO 13485 qualification
  • Simplified documental approach
  • STRUCTURED quality File system

FROM DESIGN TO CE MARK OF MEDICAL DEVICES

Product Development 

 

  • Quality by design
  • Contribution to the development of prototypes
  • PATENTING AND LIFE CYCLE MANAGMENT
  • Preclinical Evaluation
  • Product Validation

Manufacture 

 

  • Process design
  • Establish Technical Instructions
  • Liason with SubCONTRACTORS
  • desing logistics
  • License to manufacture medical device

Clinical Evaluation 

 

  • Clinical study design
  • Clinical Trial Protocol and investigator brochure
  • Liasion with ethical comitees and medical centres
  • Liason with regulatory authorities
  • Final Study Report

CE Mark

 

  • Medical Device Classification
  • Elaboration of Technical File
  • Liason with Notified Body
  • Risk Assessment
  • Submission for CE Mark

Development of Medical Devices & Diagnostics