MethodSense Supports Ulrich Medical to Fourth FDA Clearance for Innovative Computed Tomography (CT) Injector System
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MethodSense Supports Ulrich Medical to Fourth FDA Clearance for Innovative Computed Tomography (CT) Injector System
Collaboration underscores MethodSense’s role in accelerating market access and regulatory confidence for advanced medical device innovations… Morrisville, NC, January 15, 2026, MethodSense, Inc. a leading regulatory and quality consulting firm for the medical device industry, announced today that its client Ulrich Medical has received its fourth FDA clearance for the Ulrich Medical CT Motion Injector,…
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MethodSense Announces Growth Plans to Meet the Demands of a Rapidly Evolving Regulatory Landscape
With new leadership, platform innovation, and an AI-era focus, MethodSense is scaling its service offerings and software platform to help MedTech innovators meet global regulatory demands. Morrisville, NC – July 23, 2025, MethodSense, a leading regulatory and quality consulting firm for the life sciences industry, today announced a bold new phase of growth, propelled by…
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MethodSense Launches Elsa & AI Resource Center to Help Medical Device Companies Navigate the FDA’s AI Era
Morrisville, NC – July 11, 2025, MethodSense, a regulatory consulting and technology firm with more than 25 years of experience guiding medical device companies through the FDA and onto commercial markets, today announced the launch of its Elsa & AI Resource Center at MethodSense.com. This new resource hub provides critical guidance, tools, and expert insights…
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MethodSense and LuminLogic – Experience the Synergy of Technology and Expertise
Bringing a medical device to market is a complex journey, especially with the FDA’s rigorous regulatory requirements. In this video, we explore the challenges manufacturers face when navigating the regulatory process, particularly when introducing groundbreaking innovations like AI-powered devices. MethodSense, led by industry expert Rita King, provides essential support for regulated companies aiming to ensure…
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How to Structure a New Medical Device Business
There’s More to Being a Medical Device Business than IP and R&D An emerging medical device business tends to focus their energy on product development and R&D. This is understandable because medical device founders are often first experienced innovators. As innovators, there’s a natural affinity to maintain a continued focus on product development and maturation.…
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Meet FDA Requirements for Medical Device Company Compliance
Most medical device executives know they need FDA clearance to legally market and promote their product in the U.S. Beyond FDA approval, understanding how to effectively commercialize a medical device product means adapting to industry and legal expectations for operating as a medical device company. These expectations ensure that you deliver safe and effective products.…