Certifications

Quality Medical Devices & Certified Clean Room

Southmedic specializes in the manufacturing of products for the medical and electronic industries. We have earned a worldwide reputation for quality, product design and innovation in the manufacturing of medical anaesthetic components.

In December 2006, Southmedic registered for certification to:

ISO 13485:2003, MDD 93/42/EEC Annex II (European Medical Device Directive) and CMDCAS (Health Canada’s Medical Device Conformity Assessment System).

Core competencies include:
  • Design
  • Tooling
  • Cleanroom Injection Molding
  • Class 100,000 Clean Room Assembly
  • Packaging
  • Distribution
  • Regulatory Affairs Support Services
  • And always doing the right thing
Today, Southmedic holds the following certifications:

MDSAP 675962 – ISO 13485:2016

QUALITY MANAGEMENT SYSTEM – ISO 13485:2016

FM 643600 – ISO 13485:2016

QUALITY MANAGEMENT SYSTEM – ISO 13485:2016

CE 644824 – Annex V

EC CERTIFICATE - PRODUCTION QUALITY ASSURANCE

CE 644823 – Annex II

EC CERTIFICATE – FULL QUALITY ASSURANCE SYSTEM

MDEL 420

MEDICAL DEVICES ESTABLISHMENT LICENCE LISTING