Establishing an effective medical device quality management system at the beginning of the design process is essential to efficiently and effectively obtain regulatory approval for your new product idea. You need a team that understands the medical device regulation landscape in the territories that are most important for the success of your product.
At Arrotek, we have the knowledge, experience, and expertise you need.
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.