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What regulatory shifts in AI, cybersecurity, digital submissions, and capital strategy mean for your success in 2026…By Rita […]
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On this episode of MedTech Smarts with Rita, regulatory strategist Rita King breaks down what it means to […]
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On this episode of MedTech Smarts with Rita, Anna Crooke, Rita King, and Shavini Fernando dive into the […]
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This week on MedTech Smarts with Rita, the panel tackles today’s toughest funding challenges in MedTech, from shrinking […]
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This week on MedTech Smarts with Rita, we’re launching a special mini-series called “Before You Build It: Lessons […]
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On this episode of MedTech Smarts with Rita, MethodSense founder and CEO Rita King joins Anna Crooke to […]
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Elsa Signals the Start of the FDA’s AI Era. Here’s What It Means for YouBy Rita King, CEO, […]
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FDA’s AI Era Has Begun. Do You Know What it Means for Your Business? Our Elsa & AI […]
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This white paper explores the key proposed updates in the new FDA draft guidance, their implications for manufacturers, […]
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The FDA has introduced updated draft guidance to enhance the accuracy and reliability of pulse oximeters, particularly for […]
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This paper explores how medical device companies can continue to innovate while meeting the stringent requirements of MDR.
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This white paper provides insights into the FDA’s current regulatory approach to AI in medical devices, the challenges […]
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This white paper explores the FDA’s cybersecurity requirements, the challenges manufacturers face in meeting these standards, and how […]
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Bringing a medical device to market is a complex journey, especially with the FDA’s rigorous regulatory requirements. In […]
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Determining if your medical product or innovation should be considered a component or an accessory is a critical […]
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There’s More to Being a Medical Device Business than IP and R&D An emerging medical device business tends […]
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Most medical device executives know they need FDA clearance to legally market and promote their product in the […]
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An Early Practical Handle on 21 CFR Part 820 Improves Your Medical Device Business Operations The purpose of […]
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The FDA tries to track what are called “emerging safety signals.” In 2016, a study found a possible […]
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Ensuring an FDA 510(k) submission is done properly is critical to getting your medical device into the market […]
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This article originally appeared in Business Worldwide magazine. It’s fashionable to be anti-regulation in business today. But sometimes […]
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How do you know your Document Control System is working properly within your medical device company? Take this […]
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Documents, documents everywhere. But which are the records, which are documents—what is the difference and why does it […]
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Identifying and Overcoming eSTAR Challenges for a Successful Submission As of October 1, 2023, all 510(k) submissions must […]
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Quality & Regulatory Management Software Having a quality and regulatory management software solution designed specifically for life science […]
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FDA Audits Without Intimidation The healthcare industry, whether it involves pharmaceuticals, biotech treatment protocols, or medical devices, is […]
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Quality Management System Software The medical device industry is a highly regulated environment that requires a stringent adherence […]
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Medical Device Document Management & Control Medical device document management and control is essential for an effective quality […]
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You have vision—that’s why you are part of the medical device community. But to take your innovative ideas […]
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LuminLogic plays a critical role in helping businesses navigate FDA audits with ease and confidence. By providing centralized […]
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Breaking Down Silos for Enhanced Efficiency Collaboration improves outcomes, period. When there’s diverse input, varying experience, and fresh […]