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  Computational Modeling and Simulation (CMS) is Changing Medical Device Development

  Overview of computational modeling and simulation (CMS) and its impact on future medical device development.

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  A Guide to Lean and Agile Medical Device Product Development

  Guide to run a lean and agile medical device product development programs using with four considerations and key milestones.

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  Assay Verification in POC Medical Devices

  Interference Testing, Strategy, Detection Case Study examines POC medical devices assay verification guideline CLSI EP07-A2.

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  Autonomous Clinical Chemistry Assay Design Considerations to Mitigate Interference

  How an Autonomous Clinical Chemistry Assay diagnostics design with kinetic read out helps mitigate interference challenges.

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  Strategies to Maximize Outcomes During Pre-Submission Meetings

  Strategies to maximize outcomes for interactions during regulatory pre-submission meetings using 4 simple, but effective steps.

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  New FDA Cybersecurity Requirements in the US

  FDA cybersecurity requirements for medical devices which are considered “cyber devices”, including US government definition.

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  FDA and Health Canada streamline medical device submissions with joint eSTAR portal

  Overview of eSTAR, a joint Health Canada and FDA program streamlining medical device submissions with info on how to apply for the program.

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  Do VR Design Tools Live Up To The Hype?

  VR Design Tools – how does VR stack up to conventional methods in sketching and CAD? Discover areas in the design process where it excels.

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  In Silico Medical Device Drop Testing VS Benchtop

  In silico medical device drop testing offers scalability, fast-tracking of iterations, and the ability to review hard-to-detect failure modes.

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