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Navigating MedTech with Northeast Biomedical

Navigating MedTech with Northeast Biomedical

Northeast Biomedical

Listen to conversations with professionals on the way to navigate the complex and challenging path to having a device idea - going from a napkin sketch, all the way through clinical trials - and everything in-between!

6 - What is V&V Testing?
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  • 6 - What is V&V Testing?

    What does Verification & Validation (V&V) really mean in medical device development, and why is it so important? In this video, we break down the V&V process and the critical role it plays in developing safe, effective, and regulatory-ready medical devices. We’ll explore the difference between verification, "Did we build the device correctly?” and validation, “Did we build the correct device?” We’ll walk through the validation process, from defining user needs and intended use to developing validation requirements, creating test plans, using production-equivalent devices, conducting testing, analyzing results, and documenting objective evidence. We’ll look at how well-planned V&V testing can support FDA submissions, ISO 13485 QMS systems, risk management, and regulatory documentation. Whether you’re a biomedical engineer, medical device developer, startup, or established device company, understanding V&V is essential to proving that your device not only meets its specifications but works safely and effectively for the people who use it.

    Wed, 12 Aug 2026 - 36min
  • 5 - Project Planning & Management

    🎙️ Join Jack, Tim, and Phil from Northeast Biomedical as they share crucial strategies for successful project planning and management in the medical device industry.

    Don’t miss out on valuable knowledge that could revolutionize your approach to healthcare technology projects. 🏥💡

    Tune in to gain exclusive insights and practical advice from industry experts on Navigating MedTech with Northeast Biomedical. 🎧✨


    Thu, 11 Jul 2024 - 41min
  • 4 - Women in MedTech

    🎙️ In this empowering episode of Navigating MedTech, Nicole Kalil, former Fortune 100 C-suite executive and host of the "This Is Woman's Work" podcast, joins our team of female engineers for an insightful conversation. 🏥

    Together, they delve into Nicole's latest book, "Validation Is for Parking," exploring powerful strategies to nurture inner trust and reclaim personal confidence. Tune in as they share practical insights and inspiring stories that resonate across industries. 💡

    Don't miss out on this enriching discussion on Navigating MedTech 🎧✨

    Tue, 09 Jul 2024 - 1h 07min
  • 3 - Prototyping and Rapid Iterations

    🎙️ Hello listeners! Ready to dive into the world of biomedical innovation? Join Tim, Phil, and Jack from Northeast Biomedical as they uncover the intricacies of the prototyping process from start to finish—what it involves, what to expect along the way, and the inevitable iterations that refine each prototype into a market-ready solution. 🧬💡

    Tune in to gain exclusive insights and practical advice on Navigating MedTech. 🎧✨

    Thu, 05 Oct 2023 - 32min
  • 2 - Who is Your Customer?

    🎙️ Join Tim, Phil, and Jack from Northeast Biomedical as they delve deep into the critical importance of understanding your customer in the product development process. 🧬💡

    In this episode, we explore effective strategies for identifying customer personas, integrating feedback into design, and leveraging market research to create impactful medical devices.

    Tune in to gain valuable insights and actionable tips from industry experts on Navigating MedTech with Northeast Biomedical. 🎧✨

    Thu, 05 Oct 2023 - 31min
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