Quality Standards, Bluetooth & VR: Orthogonal's MedTech Insights
Orthogonal
Accelerating SaMD Development to Improve Patient Lives | ISO 13485 & HIPAA Certified | Class I-III Device Experts
Unlocking Quality in Digital Health
Our recent webinar with the Digital Medicine Society (DiMe) explored their innovative DiMe Seal initiative – an independently awarded quality benchmark for digital health products. Industry experts discussed how this seal could become a vital symbol of trustworthiness for SaMD, DTx and connected medical devices.
Navigating the complexities of ongoing releases for SaMD?
Orthogonal can help evolve your SaMD while maintaining compliance. Contact us for guidance on your next release.
Are software developers from Mars and MedTech experts from Venus?
Discover how to harmonize agile software development with medical device regulations in our latest article, “Actual Quality is the Best Measure of Quality.” This “draft manifesto” by Randy Horton and Ian Sutcliffe needs your input. Read it now and share your thoughts!
Megan Graham Joins Orthogonal as VP of Regulatory and Quality
Orthogonal welcomes Megan Graham as VP of Regulatory and Quality! With 25+ years at Medtronic and Mayo Clinic, she brings expertise in AI/ML and healthcare compliance. Megan will guide our MedTech clients through digital health regulations, accelerating innovative solutions to market.
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Explore the latest FDA-cleared Bluetooth medical devices of 2024. Our updated blog showcases innovative technologies enhancing patient care through wireless connectivity. From wearables to implantables, see how these devices are improving monitoring, treatment, and data sharing in healthcare.
Spotlight: MedTech Innovators at Orthogonal
Larkin, our CTO, is turning the MedTech world on its head with AI wizardry and a knack for building powerhouse tech teams. Meanwhile, Melissa, our VP of Delivery, brings street smarts from the tech trenches to create solutions that improve patient outcomes.
About Us
Orthogonal is a software development consulting firm that improves patient outcomes faster by helping MedTech firms accelerate their development of?Software as a Medical Device (SaMD), digital therapeutics (DTx) and connected medical device systems.?We do this by fusing modern software development and product management techniques developed in other industries (such as Agile, Lean Startup, DevOps, User-Centered Design and Systems Thinking) with the regulated focus on safety and effectiveness that is at the heart of the medical device sector. For almost fifteen years, we’ve helped a wide variety of firms in MedTech, pharma and consumer electronics develop and bring their regulated/connected devices to market including Tandem Diabetes Care, Quidel, Medtronic, Novo Nordisk, Eli Lilly, physIQ, Nanowear, Google and HeartSciences.
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3 周Orthogonal Randy Horton "Are software developers from Mars and MedTech experts from Venus?" That's a great header. My first thought on seeing it was "I bet Randy wrote that"