Our Qualification
Experience-Driven Testing for Reliable Outcomes
We Start with the Right Testing
to Accelerate the Whole Process
Our extensive industry experience, relevant educational backgrounds and credibility in quality testing make us an invaluable resource for researchers and medical device manufacturers seeking confidence in project success.
We do the right testing from the start to generate the right data and provide an experience-based perspective on how to effectively use it. Few organizations have been more innovative and integrative than ours in the realms of bioactive surface testing, antimicrobial surface testing and immune response testing.
Our Difference
- In vitro bioactive surface testing is historically difficult to evaluate. Get clarity from in-depth research performed by our biologists, chemists and physicists.
- Some solutions uncover only surface-level outcomes, but we look far beyond.
- We address clients’ most complex and challenging project requirements with new methodologies and assays.
- Our evidence – and data-based recommendations make testing easier to evaluate.
The bottom line: the right testing accelerates the process of bringing unique, life-changing medical devices to market.
You Will Spend Less Time and Money in Development
Get clarity throughout research and development to deliver results at lower cost. Swift timelines and minimal spend can be critical to a successful launch, and both of these elements can be achieved with our expertise, processes and technology.
Our Difference
- Our laboratories are equipped to quickly screen a wide range of surfaces for bioactive performance, which facilitates and expedites the development of medical devices and surface modifications.
- Our field-tested processes result in less time and money spent in development.
- We have multidisciplinary experience and knowledge in mammalian cell testing and microbiology.
- Our multidisciplinary expertise empowers us to identify and develop unique solutions to clients’ problems.
- We provide a “fast fail” stage-gate process without the long lead times associated with other labs.
In short, we offer third-party validation results faster and at lower cost than typical research labs – and we have the expertise to interpret those results.
Your Product Will Launch More Swiftly with Clear Scientific Writing and Support
We transform data directly into publication-ready white papers and FDA-submittable scientific writing to support medical device launches and eliminate time lost getting to market. Our team has completed extensive scientific writing for varied uses in multiple areas and is all too familiar with the demands of scientific journals and the FDA.
Our Difference
- We concisely and simply capture the performance of the device’s surface, moving it more swiftly to market.
- Apart from premium writing services, we also offer consulting support to help with data interpretation as well as project management.
- In assisting clients to organize, plan and control each project, we help identify problems early in development and maximize assurance and confidence of project success.
- Our personnel support is ideal for medical device companies with insufficient internal resources or surface technical expertise.
- Personnel support includes literature search, analysis and data presentation in a format that can be used to promote a project internally or for regulatory submission.
We support clients beyond testing with exemplary scientific writing at every step of the process.
