"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
Quality Means Business
医疗和诊断实验室
Boston,Massachusetts 717 位关注者
Quality makes the human experience better.
关于我们
QMB is a strategic consulting partner in transforming quality and Regulatory business units from a cost center to a profit driver. We utilize our collective experience in RA/QA, Product Development, Strategy, Market, and Clinical Research to develop and deploy strategic quality management systems, develop FDA product submissions, empower clinical trial management, and actualize regulatory requirements. We assist and work with your in-house regulatory and product development teams to ensure optimal results. Our other passion: By compiling our industry experience, we are taking the world of regulatory product clearances and approvals into the next phase by developing a new AI-native platform called QualiVerse ?. This platform will be able to automate the heavily manual nature of regulatory research and product strategy, accelerate the planning and implementation of submissions, and de-risk the highly demanding submission preparation process. Follow QualiVerse_AI on LinkedIn.
- 网站
-
https://www.qmbdevices.com
Quality Means Business的外部链接
- 所属行业
- 医疗和诊断实验室
- 规模
- 2-10 人
- 总部
- Boston,Massachusetts
- 类型
- 私人持股
- 创立
- 2020
- 领域
- Combination Product、Medical Device、US FDA、EU EMA、Pharmaceutical、PMA、RA/QA 、510K submissions和Regulatory Strategy
地点
-
主要
867 Boylston St
5th Floor, Suite #1472
US,Massachusetts,Boston,02116
Quality Means Business员工
-
Arthur Lee
AI, ML, data & analytic software solution innovator and leader
-
Darwin Shurig
Recruiter: Leadership for CMO, Clinical, RA/QA & Engineering Top Talent in the Medical Device, IVD, Pharma and C> Industry
-
Michel E. Moravia, MBA, MSE
Chief Executive Officer at Quality Means Business | 40 under 40 | GenAI Expert | Life Science Quality & Regulatory Leader
-
Dale Jones
Principal Consultant at Exergen Corporation
动态
-
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
Medtronic recalls McGrath Mac laryngoscope due to potential for explosions
https://www.massdevice.com
-
Chief Executive Officer at Quality Means Business | 40 under 40 | GenAI Expert | Life Science Quality & Regulatory Leader
Here's a strong frameworks for adopting Generative AI in Healthcare/ Life Science in a Safe and Responsible manner. A systems approach (SBOM or AIOps) for demonstrating control will likely prove to be game-changer. Thanks Bakul Patel at Google Health for your exemplary insights. #generativeai #responsibleai #safeai #lifescience #medtech #biotech #aiops #mlops #trainingdata #pccp #trainingplans #knowkedgegraphs #llms #validation #fda
How to Regulate Generative AI in Health Care
hbr.org