Quality Systems
Our ISO 13485 quality system guides every product we make. We are committed to exceeding our customer’s needs by providing the highest quality products and service, on time and within budget.
VascuTech Medical system has been structured to assure conformity with the applicable requirements of the ISO 13485:2016 standard & the Food and Drug Administration (FDA) Quality System Regulation, 21 CFR Part 820 for medical devices.
VascuTech Medical supports customer requirements for obtaining clearance to market medical devices by providing effective support to regulatory submissions and assuring that activities performed by VascuTech Medical conform to associated standards and regulatory requirements.
We are committed to exceeding our customer’s needs by providing the highest quality products and service, on time and within budget
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How Our ISO 13485 Quality System Works
An ISO 13485 quality system defines how a medical device company controls design, production, inspection and documentation. The ISO 13485 standard is the internationally recognized framework for medical device quality management.
At VascuTech Medical, our ISO 13485 quality system is also structured to align with the FDA Quality Management System Regulation, 21 CFR Part 820. These controls support the documentation our customers need for regulatory submissions and help keep every lot consistent.
Our quality team works alongside process development and production from the start of each project. Contact us to discuss documentation or quality requirements.
Our quality system covers incoming inspection, in-process checks and final inspection, along with document control, training, calibration and corrective and preventive action. Each lot is documented so that results are traceable back to materials and process settings.
Why partner with VascuTech Medical? Founded in 2009 by a mechanical engineer, we focus on efficient, minimalist designs and manufacture 100% in the USA. As a vertically integrated facility, we complete work in-house quickly and precisely, without outsourcing delays or added expense, and we stay price competitive while supporting better patient outcomes. Browse our products to see these capabilities at work.