Comprehensive Testing Services for Combination Products

EdgeOne Medical offers industry leading testing services for combination products, from early feasibility testing to design verification to post-market support. Our in-house, FDA and EMA registered labs ensure your product is tested in compliance with the highest industry standards.

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Your Remote Device Testing Laboratory

We recognize that design verification testing is the culmination of all device development efforts, where critical data is generated. With regulatory submissions often hinging on successful verification testing packages, getting it right is essential to your products success.

We also recognize and highly value the trust our clients place in us to perform these critical testing activities. As your testing partner, we assume responsibility as your eyes and ears in the lab. This inherently makes our approach to testing non-transactional.

How We're Different

  • Our lab facilities have successfully been inspected by the FDA.
  • We ask questions before we start testing and if we know something you don’t, we’ll share.
  • Engineers, not lab techs, perform the testing.
  • We don’t just tell you there’s an issue; We dive deep to investigate and help solve the issue.
  • We're unbiased in our evaluations because we are independent from the device designers and manufacturers
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Comprehensive Testing Services for All Device Stages

EdgeOne Medical’s testing experience covers a wide range of combination products, from common configurations such as pre-filled syringes, injectors and inhalers to complex, custom device systems used for intrathecal delivery of a gene therapy. We integrate data integrity throughout our testing process and leverage our expertise to ensure your product meets all applicable regulatory and performance standards. The following are the most requested testing services by our large pharma clients.

Test Method Validation

We provide full support for development and validation of test methods, including design and fabrication of necessary test fixtures and surrogate samples.

If needed, we’ll transfer the method to your internal device lab or manufacturing facility.

Also, our method development and validation work isn’t limited to those defined in standards. We enjoy operating in ambiguity and taking on the challenge of developing and validating new methods whenever needed.

Verification and Aging Studies

Our comprehensive design verification testing package includes establishing the verification and validation testing strategy, performing all testing, issuing complete documentation package (protocol/reports), while also managing the conditioning for distribution, real-time and accelerated aging testing.

Our design verification test reports are often included directly into the regulatory submission packages. This is intentional. We understand the data packages needed for a successful submission and are confident in the quality of our work.

Issue Resolution

Issues happen! As a non-transactional testing lab, when issues do arise, our engineering team engages with you to identify the root cause of failure and present options for resolution. Getting issues resolved in a timely manner is critical to getting programs back on track.

Even if we aren’t supporting your verification testing program, bring us your issues. We solve a variety of technical device issues throughout all stages of the product life cycle.

Other Critical Testing Support

Our comprehensive testing services are bookended by early feasibility testing and market expansion studies.

Feasibility studies help establish confidence in performance of product configuration prior to initiation of formal design verification studies, while market expansion studies often include conducting subsets of tests using device systems that are specific to the region of interest.

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EdgeOne’s Testing Program Process

With over 50 design verification programs successfully completed, we’ve modeled our testing process to simplify onboarding and execution of new testing programs. If you’d like to learn more about our process, click the button below.

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The EdgeOne Advantage

We’ve been testing combination products in our labs per device design control regulations since before the FDA issued formal guidance in 2014. This gives us a longer track record than any other combination product testing service provider in the industry. Our collective, institutional knowledge on testing combination products runs deeper and wider than our competition.

Experience Materialized

  • A library of validated test methods ready to support common device systems.
  • A clearly defined and repeatable process for testing programs
  • Efficient execution of testing programs for our clients.
  • A smooth regulatory review process when our test reports accompany the submission.

Testing Capabilities 

  • Feasibility Testing
  • Test Method Development & Validation
  • Fixture Design and Fabrication
  • Pre-Design Verification Testing
  • Design Verification Testing & Management
  • Aging Studies: Real-Time & Accelerated Testing & Management
  • Sample Conditioning
  • Simulated Distribution Conditioning
  • Complaint Investigations
  • Release Testing
  • Device Failure Investigations and Root Cause Analysis
  • Life Cycle Management Changes: Supplier Notification Change (SNC) or Global Expansion

Sampling of Industry Standards we Support

Develop and validate custom test methods when existing industry standards don’t apply, ensuring accurate and reliable results.

  • ISO 11608-1
  • ISO 11040-4 and -8
  • Others…

Ready to Bring Your Product to Market with Confidence?

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