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Predicate device

Access to a diverse range of predicate devices, covering a wide range of medical indications and device types

We support medical device manufacturers in their efforts to demonstrate substantial equivalence to bring devices to market more quickly and with greater confidence.

Cross-platform capability

We offer experience and expertise across a wide range of devices, technologies, and platforms to accommodate your specific needs and requirements for testing your device performance, durability, and user-centered design

  -  State-of-the-art testing equipment and technology

  -  Broad array of instrumentation

  -  Expertise in specialized platforms and assays

  -  Software for analyzing data and generating reports

  -  Bioinformatics expertise


Bring Your Own Device

We offer our clients the flexibility to bring their own instruments and predicate devices into our lab environment.


With 140,000 sqft of lab space, within our network of labs, our facilities are designed to accommodate a wide range of research instruments and equipment. Our team of experts can provide guidance on best practices for integrating your instruments into our lab environment.

An image of a laboratory professional doing genetics testing

We work on diagnostic trials of every kind

Regardless of size, population, setting, stage, or pathway, we can serve as an extension of your development team to successfully execute on all phases of your medical device and diagnostic trials.

Review methods, procedures, and documentation to provide the data to prove they can be accurately repeated

Generate the data and information that compares your new device to a predicate device

  • Identify to address design issues that may affect the usability, safety, or effectiveness of your device or diagnostic
  • Data to identify areas for improvement that will enhance safety, usability, and performance

  • Identify the relative benefits and risks
  • Evidence-based
  • Parallel or crossover study design
  • Data for device effectiveness and safety

Let's discuss your project

Contact our pharma solutions experts to design a custom program to accommodate the needs of your study.

Let's talk