Quality & compliance
Certifications & Quality
Every Pak Line instrument is produced under a documented quality management system with full batch traceability.
ISOISO 13485:2016Medical devices QMS
FDAFDA RegisteredUS establishment listing
MDREU MDR 2017/745Compliant documentation
CECE MarkedEuropean conformity
What this means for you
- ISO 13485:2016 — our quality management system for medical device design and manufacture is independently certified.
- FDA registration — our establishment is registered for supplying instruments to the United States.
- EU MDR 2017/745 & CE — technical documentation and CE marking for instruments sold in the European Union.
- ISO 7153-1 — stainless steel grades conform to the international standard for surgical instrument materials.
Copies of certificates, declarations of conformity and material test reports are available on request for tenders and distributor registration.