A Seisa Medical

Company

  © 2019 by Burpee MedSystems

+

OUR

QUALITY

POLICY

Burpee MedSystems will not sacrifice product quality to gain advantage in other aspects of our business.  Our clients depend on our integrity, and the consistent high quality of the products we provide.  It is our goal to provide excellent products that meet/exceed customer expectations, while also meeting applicable statutory requirements and national/international standards.

Quality is our #1 priority

At Burpee MedSystems, we design and manufacture components and finished medical devices that will directly impact the lives of patients all around the world.  That's why we are committed to achieving the highest possible standards of quality in everything we do.

BSI-Assurance-Mark-ISO-13485-KEYB.jpg

With 20+ years of medical device experience, we have developed a thorough understanding of the complex regulatory environment.  From concept through validation, our team designs with regulatory compliance in mind.  Our products are regulatory compliant and manufactured in our ISO-certified facility.

+    ISO 13485:2003 Certified

+    ISO 7 Class 10,000 Certified Cleanroom

     Controlled Environments

+    FDA Registered and compliant with the

     Quality System Regulation

+    Class I, II, and III devices, including

     Pre-Market Approval (PMA) Products

Certifications