Certification

ARTHESYS  is ISO 13485 certified with LNE-Gmed, and is GMP compliant; its facilities are FDA registered. All our products are CE marked, whether sterile or non-sterile.

ARTHESYS' facility has over 2750 m2 with 4 clean rooms over 700 m2 in France and 300m2 in India.

Quality Control

ARTHESYS proceeds to 100% non-destructive inspection during the manufacturing of the products. Each lot is again inspected by our QC department, with partly destructive tests based on various sampling levels. Our philosophy is to always focus on no compromise with the quality of the products we deliver, to ensure customer satisfaction, successful interventions and safety to patients.

Regulatory affairs

We provide a dedicated regulatory affairs department for our client’s CE file setup, and assist them in achieving local approvals in any and all parts of the world.

Quality assurance

Our Quality Assurance department employs the Ishikawa diagram problem solving method for tackling and resolving problems. The method is comprised of the following:

  • Equipment analysis
  • Process analysis
  • People analysis
  • Material analysis
  • Environment analysis
  • Management analysis.