Quality Means Business

Gen AI + FDA ! The FDA is intensifying its oversight of artificial intelligence (AI) applications in healthcare, aiming to ensure patient safety and efficacy. This move aims to address concerns about algorithmic bias, transparency, and the need for rigorous validation of AI tools before their clinical deployment. The FDA’s approach includes developing tailored regulatory frameworks and promoting Good Machine Learning Practices (GMLP) to guide the development and implementation of AI in medical devices. By establishing these guidelines, the FDA seeks to balance innovation with patient safety, ensuring that AI technologies enhance healthcare outcomes without compromising standards. Interesting to see how the new administration tackles these important and massively consequential decisions. 2025 will be an important year ! #ai C10 Labs #healthcare #appliedAi. https://lnkd.in/etmRFSnU

"The National Institutes of Health (NIH) has unveiled a new artificial intelligence (AI) algorithm designed to more efficiently match potential clinical trial participants to appropriate studies." https://lnkd.in/gnRyUVZd

On October 22nd, QMB founders proudly supported the Biomedical Science Careers Program (BSCP). Michel E. Moravia, MBA, MSE, and Thaina Cynthia Moravia-Roman, AGPCNP-BC, ANP-C, AGPCNP-BC, ANP-C, both benefited from this amazing program's dedication to fostering academically outstanding underrepresented minorities in science and medicine. "Since its inception, more than 13,000 minority students and 1,200 underrepresented postdoctoral trainees and junior faculty members have participated in BSCP programs." Henry Kim Christopher Wallace Leonard Glatkowski Tanima Ghosh Julian Weinstock

?? The Investor Catalyst (IC) Hub spoke network operates collectively to accelerate the commercialization of groundbreaking health innovations. Spoke members represent the private, public, and nonprofit sectors. By joining the network, you gain the opportunity to connect with diverse IC Hub spokes, including: AcousticaBio Celdara Medical CASPR - Center for Addiction Science, Policy, and Research Clean Box Enterprise Inc Gals Bio Ltd Glendor, Inc Quality Means Business Safe Health Apply now! → https://bit.ly/4atwMS7 Advanced Research Projects Agency for Health (ARPA-H) #ARPANETH

Quality Means Business was honored to be invited to Nectar Community Investments' re-branding opening ceremony, a momentous event that truly highlighted the incredible impact that Nectar has on our communities and local small businesses. The energy in the room was inspiring as we witnessed firsthand how their dedicated efforts are shaping the future of community development. Nectar Community Investments continues to be a pillar of support, providing invaluable resources and opportunities for small businesses to thrive. Their commitment to fostering growth and creating sustainable solutions is integral to the fabric of our neighborhoods. It's clear that the positive effects of their work are felt far and wide, touching the lives of so many through strategic investments, mentorship, and a relentless focus on community-driven success. We’re excited about their next chapter and proud to be a part of their journey. Thank you, Nectar Community Investments, for being a beacon of hope and opportunity in the community. You are paving the way for so many to succeed! #CommunityFirst #SmallBusinessGrowth #NectarInvests #CommunityImpact #LocalBusinessSupport #QualityMeansBusiness #MedicalDevices #fda #CombinationProducts #BusinessWithPurpose #SustainableGrowth

QMB QualiVerse_AI is proud to be a Platinum Sponsor for the upcoming CAPRA - Canadian Association of Professionals in Regulatory Affairs Pharmaceutical Symposium this October. We look forward to engaging industry leaders and regulatory colleagues at this event! Michel E. Moravia, MBA, MSE Henry Kim Leonard Glatkowski Tanima Ghosh

QMB is proud to join the Investor Catalyst Hub, a fantastic collaborative ecosystem for addressing complex public health problems. We look forward to working with multiple stakeholders to accelerate medical breakthroughs! Thank you to C10 Labs for bringing us together. Michel E. Moravia, MBA, MSE Henry Kim Julian Weinstock Leonard Glatkowski Christopher Wallace #FDAregulatory #Medtech #qms

Attending Startup Boston this week was an incredible experience, but what truly stood out were the insightful panel sessions that dove deep into the challenges and opportunities facing today's entrepreneurs. The wealth of knowledge shared has reinvigorated our drive at Quality Means Business to disrupt the MedTech landscape through AI/ML. Key Panel Highlights: AI Startup Scaling & Pivoting Tactics: The panel shed light on the importance of adaptability in the fast-moving AI space. Experts like Shahid Azim and company discussed effective strategies for scaling via robust technological infrastructures. Data Strategy for Growth: Data is the backbone of every modern business, and this session dove into understanding what is needed to build a strong foundation - like who to hire first. Data engineers are invaluable in structuring the schema you will utilize moving forward. From data collection to actionable insights, the focus was on making data-driven decisions that align with long-term goals. It was fascinating to learn how the right data strategy can unlock new revenue streams and improve operational efficiency. True Competitive Analysis: Understanding your true competition—not just direct competitors but indirect ones as well, will make or break you. The experts highlighted tools and techniques to conduct deeper competitive analyses that go beyond surface-level research, helping businesses uncover hidden threats and opportunities. This deep dive into competitive intelligence was invaluable for anyone looking to differentiate and stay ahead in the market. ?? Biggest Takeaway: Whether you're scaling, pivoting, or refining your strategy, staying data-informed and competitive is critical in today’s fast-paced startup world. These sessions provided the kind of actionable insights that are essential for long-term success. A massive thank you to the brilliant minds who shared their expertise and Stephanie Roulic of StartUp Boston for making it all possible! ?? If you attended, I'd love to hear your thoughts and takeaways. Let’s keep the conversation going! #StartupBoston #AI #DataStrategy #Scaling #CompetitiveAnalysis #Entrepreneurship #Innovation #Pivoting #Startups #Quality #fda #medicaldevices #QualityMeansBusiness

"The US Food and Drug Administration (FDA) has tagged?Abbott’s recent recall of its faulty FreeStyle Libre 3 sensors as Class I, the most serious designation the agency can hand out for a recall." Henry Kim Michel E. Moravia, MBA, MSE Leonard Glatkowski https://lnkd.in/d7e4d8ea

"The FDA issued a notice deeming a recall of?Medtronic?(NYSE: MDT) McGrath Mac video laryngoscopes Class I, the most serious kind." https://lnkd.in/dcJsHGr5