Certifications & Regulatory

FDA Registrations

AngioSystems is registered with the FDA as a medical device manufacturer, and our product lines are listed with the FDA. In order to validate our procedures, polices, and processes AngioSystems undergoes both periodic scheduled audits from the FDA, as well as, unannounced audits. For example, AngioSystems is in the process of implementing UDI compliance on all of its labels and as of September, 2016 our surgical drape labels are UDI compliant. Our other products will follow in accordance with the FDA UDI mandated schedule. 

ISO Certifications

AngioSystems has been ISO 13485 certified since 2006 and with it our products are CE marked for sales in those countries that require it. AngioSystems has developed, maintained, and is continually improving our procedures, policies, and processes to meet and exceed these standards in order to better serve our customers. We undergo annual ISO audits and facility inspections and use these audits as opportunities to learn more about improving ourselves for our customers benefit. Mdi Europa is our Authorized Representative partner for ISO in Europe. SGS North America partners with us to perform our ISO audits. 

FDA Device Listing for Trays

FDA Device Listing for Drapes

Current ISO Certificate

Current MDD 93/42/EEC for Surgical Drapes and SorbX