Certifications

Several monitoring and control activities are arranged in the production chain,starting from the incoming until the final release. Accurate visual and dimensional inspections, functional and resistance testings are performed during all production phases.

To obtain these results, all business processes are designed to ensure compliance with regulatory requirements and regulatory reference. All companies in the group apply and keep updated the quality management system as certified by ISO 13485, as well as their CE certification for different families of medical devices..

ISO CERTIFICATE

  • ISO 13485:2016

CE CERTIFICATE

  • 1668 MDD – Class IIa

 

  • 1669 MDD – Class Is

QUALITY SYSTEM

System

  • Quality Management System certified according to international standards
  • ISO 13485 certification
  • CE certification in compliance to Directive 93/42/CEE
  • Structured system of procedures and instructions studied to cover all processes
  • Critical processes validation

…we plan our quality

Control

  • Documented Quality Controls System in all production phases:
    • Incoming inspections
    • In-process inspections
    • Final inspections
  • Quality control plans according to ISO 2859 standard
  • Visual, dimensional, functional and technical tests on products
  • Technological advanced test equipment
  • Inline measuring of the tubes diameter

…we check our quality

Inspection equipments

  • Three-Axis Optical Measuring System with Renishaw Touch Probe
  • Profile Projectors
  • Inline laser for tubes diameter measuring
  • Force testing equipment (Traction and Compression)
  • Peel Force testing equipment
  • Leakage pressure equipment up to 6 bar

…we guarantee our quality

HMC GROUP: QUALITY SYSTEM