Testing & Verification – Enabling the Best Decisions for Your Success

From the start of the development process of your medical device, you need to make decisions. Design, materials, manufacturing processes, sterilization method… the list of decisions can almost seem endless. How do you know if you’ve made the right decisions? Information is the key, and testing is the way to get it.

We offer a complete portfolio of analysis and testing services conforming to ISO/ASTM standards and performed by our own, highly skilled engineers and technicians. Here’s a glimpse of what we can utilize on your project:

  • Metrology
  • Mechanical Performance
  • Reliability/Lifecycle Testing
  • Flow Rate and Pressure Testing
  • Competitive/Benchmark Analysis
  • ISO/DIN/ASTM Testing (e.g. ISO 594)
  • Accelerated Aging/Environmental Conditioning
  • Pre-clinical Testing
  • Simulated Use
  • Formative and Summative Studies
  • Package Integrity Testing, including Transportation
  • Microbiology (e.g. Microbial Ingress)
  • Biocompatibility Testing
  • Bioburden Testing
  • Sterilization Validation

Partnering with us for testing services gets you more than just raw data. We turn that data into meaningful information and well-thought out recommendations so you have what you need to make informed decisions. The best decisions, and success, come from the best information. Working with us, you get it.

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Testing & Verification – Enabling the Best Decisions for Your Success

Patient safety. Product performance. Regulatory compliance. Three key aspects when it comes to medical device innovations. Failing on any front is not an option if you want to make it to market. Our testing capabilities and expertise will help you make the right decisions to move forward.

We perform a variety of testing services to ensure the integrity of your medical device, its packaging, and compliance with recognized standards required for regulatory (FDA 510(K), CE, etc.) submissions.

Testing Type
Purpose
Testing Attributes
Environmental
Ensure clean room is performing to Class (ISO) 8 specifications
  • Heat
  • Temperature
  • Humidity
  • Bacteria Identification
  • Monitor surfaces, air and devices
Microbial
Test bioburden counts on parts and equipment
  • Two-stage bacterial incubation process
  • Anaerobic incubation
  • Probiotic incubation
Product & Packaging
Meet and exceed ISO 594 standards for components and ensure product performance
  • Metrology
  • Mechanical performance
  • Reliability/lifecycle testing
  • Flow rate and pressure testing
  • Accelerated aging/environmental conditioning)
  • Packaging integrity testing, including transportation
  • Competitive/benchmark analysis
  • ISO/DIN/ASTM testing
  • Pre-clinical testing
  • Simulated use
  • Formative and summative studies
  • Microbiology
  • Biocompatibility testing

Our services are performed by our own skilled engineers and technicians in our on-site mechanical and microbiological testing labs. Naturally, if your project has been with us from the start, testing considerations and planning are built into the process for your FDA 510(k) or other regulatory submission.

Coming to us in the middle of the development process? That’s okay. We can perform custom testing to your specifications and also help you with post-market surveillance and competitive/benchmark analysis.

Testing is critical to move your device from start to finish. Whether you need engineering evaluations, formative studies, design verification or even process qualifications, you’re covered. In the end, partnering with us gives you more than just raw data. You get our interpretation of the data and our recommendations on what to do next to ensure patient safety and product performance. That’s what it’s really all about… helping you make the best decisions so that you succeed in crossing the finish line.