13485 Design Company – Helping You Obtain EU and FDA Certification
We value and understand the importance of complete dependability both in terms of the service we provide and the product we help you develop.
As a result, everything we do at Arrotek is carried out in accordance with our ISO 13485:2016 & EN ISO 13485:2016 accredited Quality Management System for medical devices. This certification relates to:
“Contract design, development, manufacture and packaging of sterile and non-sterile plastic-based medical devices: needles, sheaths, catheters, introducers, handles, dilators, leads and delivery systems to customer specifications.”
You can view our certification here.