Finding the Right Test Equipment in the Medical Device Industry can be Challenging
It can be very difficult to find “off-the-shelf” equipment that meets a manufacturer’s needs. At STERIS we understand this challenge and utilize our extensive testing knowledge to deliver custom solutions. We build a wide range of laboratory and in-line test equipment, offering both standard and custom configurations to suit our Customers’ particular requirements and deliver to the necessary international standards.
STERIS has extensive experience in developing test systems to provide for non-technical operators as well as flexible test systems for technical operator requirements.
Examples of Test Systems Include:
- Electronic systems
- Mechatronic systems
- Fluid dynamic systems
- Medical equipment test systems
- Medical device test systems
- Electronic measurement systems
- PLC and PC based controls (positive pressure, vacuum, flow and micro flow, temperature, force and dimensional analysis)
- Flexible test systems – to meet both development and longer-term product testing needs
Examples of Test System Applications:
- Catheter dynamic flow/burst testing (R&D/validation)
- Catheter lubricity testing (validation)
- R&D laboratory and in-line applications (R&D)
- Non-technical operation (Go, No-Go)
- Automatic stiffness (catheter/wire) test system (R&D / validation)
- Automatic processing and measuring aids (micro wire markers) (manufacturing)
- Non-standard implant device fatigue tester (validation)
- Micro device leak/burst testing (R&D / validation)
- Drug delivery pump flow & leak tests (validation / manufacturing)
- Sphincter device seal integrity tester (R&D / validation)
- Device attachment tests (R&D)
- Life cycle reliability mechanical test rigs (validation)
- Torsion test for wire along tortuous path (R&D / validation)
- Systems built to international standards and CE certified where required
- Validation of equipment can be provided to required levels
- Hardware design using various bus structures, IEEE, USB, HDMI, LAN, CAN etc.
- Integration of e-relative OEM instruments
- Development of software interface, Visual C, Visual Basic, LabView, Lab Windows etc.
- Development of unique interface fixtures to accommodate product Unit Under Test (UUT)
- Factory and site acceptance testing (FAT and SAT)
- IQ (installation qualification), OQ (operational qualification), PQ (performance qualification)
- Calibration of equipment
From ISO 594 to ISO 80369: Making Sense of the Latest Luer Requirements
STERIS has prepared a short white paper outlining the most important requirements to adhere to for achieving compliance with ISO 80369-7.
The Importance of Risk Assessment
Due to the all-consuming nature of designing a brand new product, developers are frequently more focused on functionality than risk.
Defining a Family of Products to Economize Package Testing
Does every medical device’s packaging system need to be tested separately?
Avoiding Medicine Spoilage During Transportation and Storage
In an industry requiring the transportation and storage of millions of biologics every year, how do we avoid spoilage?