A Seisa Medical

Company

  © 2019 by Burpee MedSystems

QUALITY

by design

+

Client satisfaction is our prime objective

Our rigorous Quality Control system ensures that consistent high quality product is being produced and shipped.  Whether the product is in Design + Development or Manufacturing + Assembly, our QC system will meet or exceed customer expectations.

Inspection and Test Equipment Capabilities

+    High throughput, automated Stent Inspection Systems

+    Automated Vision Measurement System

+    Digital measuring microscopes

+    Optical Comparators

+    Custom calibrated measurement fixtures for product specific 

     dimension

+    Experienced team of visual inspection technicians

Test Methods

+     Bend and Free Recovery Test

         Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys

         (ASTM F2082)

+    Radial Outward Force for Self-Expanding Stents

        Cardiovascular implants - Endovascular devices - Part 1: Endovascular Prostheses

        (ISO 25539-1)

+    Measuring Intrinsic Elastic Recoil of Balloon-Expandable

     Stents

       (ASTM F2079)

+    Radial Stiffness and Strength Test for Balloon Expandable

     Stents

+    Three-Point Bending of Balloon Expandable Vascular

     Stents and Stent Systems

       (ASTM F2606)

+    In-Vitro Pulsatile Durability Testing of Vascular Stents

       (ASTM F2477)

+    Simulated Use Testing per FDA Guidance

 

+    Kink and Crush Resistance per FDA Guidance

 

+    Seal Strength of Flexible Barrier Materials

        (ASTM F88/F88M)

 

+    Detecting Seal Leaks in Porous Medical Packaging by Dye

     Penetration

       (ASTM F1929)

 

+    Detecting Gross Leaks in Packaging by Internal

     Pressurization (Bubble Leak Test)

       (ASTM F2096)

 

+    Nitrogen and Gas Leak Test

 

+    Stent Delivery System Bond Strength

        Intravascular Catheters - Sterile and Single-Use Catheters

        (ISO 10555-1)