A Seisa Medical

Company

  © 2019 by Burpee MedSystems

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Quality Assurance

Burpee MedSystems Quality Assurance System is designed to ensure product quality and customer satisfaction from the first conceptual prototype order through full scale production of not only stents, but catheter or delivery system manufacturing, sterilization, and final labeling and packaging.  Our unique ISO 13485 / 9001 Quality System allows for unburdened rapid turn-around prototyping as well as including strict controls and assurance for all levels of medical device manufacturing.

Quality Assurance Capabilities

+     FDA Registered Medical Device Establishment

+    Process Characterization with Design of Experiments (DoE)

+    Process Validation

+    Equipment Qualification

+    Risk Analysis and pFMEA

+    Lean DMAIC Process Improvement

 

+    Control Plans

 

+    Performance Capability

 

+    Attribute and Variable Sampling Plans

 

+    Sterility Assurance

 

+    Finished Device Label Printing

 

+    Device Label Inspection Specialists