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…
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…
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…
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,…