Certifications
We have earned a worldwide reputation for quality, innovative product design, and excellence in manufacturing.
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).
Our 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 0168450 – ISO 13485:2016
QUALITY MANAGEMENT SYSTEM – ISO 13485:2016
MDR 761474 - Annex IX
EU QUALITY MANAGEMENT SYSTEM CERTIFICATE
MDEL 420
MEDICAL DEVICES ESTABLISHMENT LICENCE LISTING
FM 0168451 – ISO 13485:2016
QUALITY MANAGEMENT SYSTEM – ISO 13485:2016
UKCA 766630 - Annex II
UKCA CERTIFICATE – FULL QUALITY ASSURANCE SYSTEM
ISCC-PLUS-CERT-US201-195052024
ISCC PLUS CERTIFICATE: PROCESSING UNIT – CONVERTER
Speak to Our Experts!
Have questions or need support with our medical devices or other products?
We can help. Contact us Monday to Friday from 8:30am to 5:00pm ET.
We look forward to hearing from you!