This episode breaks down why ISO 13485 certification alone does not make a MedTech company FDA-ready under QMSR, and why the real differentiator is operational readiness…
In this episode of MedTech Smarts with Rita, we break down the FDA’s new Quality Management System Regulation (QMSR), what it means for medical device companies…
2025 Successes and What They Signal for 2026 Regulatory expectations accelerated in 2025. As FDA scrutiny increased, many innovative medical device companies encountered regulatory challenges that…
In today’s MedTech market, capital increasingly flows toward companies that demonstrate credible regulatory execution and realistic milestones. Investors and strategic partners are evaluating not only innovation,…
The Corporate Backgrounder provides an overview of MethodSense, who we are, what we do, and how we help medical technology companies achieve regulatory and commercial success.…
What regulatory shifts in AI, cybersecurity, digital submissions, and capital strategy mean for your success in 2026…By Rita King, CEO & Senior Regulatory Strategist, MethodSense As…
On this episode of MedTech Smarts with Rita, regulatory strategist Rita King breaks down what it means to operate as a true medical device company, beyond…
On this episode of MedTech Smarts with Rita, Anna Crooke, Rita King, and Shavini Fernando dive into the realities of bringing a medical device to market.…
This week on MedTech Smarts with Rita, the panel tackles today’s toughest funding challenges in MedTech, from shrinking venture capital to limited grants and the impact…
This week on MedTech Smarts with Rita, we're launching a special mini-series called "Before You Build It: Lessons from 25 Years of MedTech Startups." We'll dive…
On this episode of MedTech Smarts with Rita, MethodSense founder and CEO Rita King joins Anna Crooke to take a closer look at one of the…
Elsa Signals the Start of the FDA’s AI Era. Here’s What It Means for YouBy Rita King, CEO, MethodSense The FDA just dropped a game-changer: Elsa,…
FDA’s AI Era Has Begun. Do You Know What it Means for Your Business? Our Elsa & AI Resource Center has everything you need to know…
This white paper explores the key proposed updates in the new FDA draft guidance, their implications for manufacturers, and the ways in which companies can successfully…
The FDA has introduced updated draft guidance to enhance the accuracy and reliability of pulse oximeters, particularly for diverse skin tones and pediatric populations. This fact…
This paper explores how medical device companies can continue to innovate while meeting the stringent requirements of MDR. MethodSense-MDR-Compliance-White-PaperDownload
This white paper provides insights into the FDA’s current regulatory approach to AI in medical devices, the challenges companies face, and the strategies necessary to successfully…
This white paper explores the FDA’s cybersecurity requirements, the challenges manufacturers face in meeting these standards, and how LuminLogic, a quality management platform, streamlines the compliance…
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…
Determining if your medical product or innovation should be considered a component or an accessory is a critical early-life cycle inflection point. In fact, the distinction…
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…
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…
An Early Practical Handle on 21 CFR Part 820 Improves Your Medical Device Business Operations The purpose of regulatory affairs is to ensure that your company…
The FDA tries to track what are called “emerging safety signals.” In 2016, a study found a possible link between reduced leaflet mobility in TAVRs and…
Ensuring an FDA 510(k) submission is done properly is critical to getting your medical device into the market and monetizing your development. And the speed with…
This article originally appeared in Business Worldwide magazine. It’s fashionable to be anti-regulation in business today. But sometimes regulation is central to how a sector operates.…
How do you know your Document Control System is working properly within your medical device company? Take this quick Document Control Health Check-Up Questionnaire: Do you…
Documents, documents everywhere. But which are the records, which are documents, what is the difference and why does it matter? Even start-up medical device companies are…
Identifying and Overcoming eSTAR Challenges for a Successful Submission As of October 1, 2023, all 510(k) submissions must be submitted as electronic submissions using eSTAR through…
Quality & Regulatory Management Software Having a quality and regulatory management software solution designed specifically for life science and regulated companies helps keep business processes running…
FDA Audits Without Intimidation The healthcare industry, whether it involves pharmaceuticals, biotech treatment protocols, or medical devices, is highly regulated, as it should be. Because the…
Quality Management System Software The medical device industry is a highly regulated environment that requires a stringent adherence to quality. So, you need a QMS software…
Medical Device Document Management & Control Medical device document management and control is essential for an effective quality management and regulatory compliant system, especially as your…
You have vision. That’s why you are part of the medical device community. But to take your innovative ideas to fruition, there are countless regulatory hoops…
LuminLogic plays a critical role in helping businesses navigate FDA audits with ease and confidence. By providing centralized access to all necessary documentation, LuminLogic ensures that…
Breaking Down Silos for Enhanced Efficiency Collaboration improves outcomes, period. When there’s diverse input, varying experience, and fresh insight involved, any effort will experience exponential advancement,…