The FDA’s Quality System Regulation (QSR) is evolving, and staying compliant is more critical than ever. In our latest blog post, Sally Carter, PMP breaks down the Top Five Things You Need to Know about the FDA’s updated QMSR and how its alignment with ISO 13485 impacts medical device manufacturers. ? What’s changed? ? How will it affect your business? ? What steps can you take to stay ahead? Stay informed and prepared – read the full blog now: https://lnkd.in/eRHK_hh5 #FDA #QMSR #ISO13485 #MedicalDevices #Compliance #QualityManagement #Cognition #CompassMED #ProductDevelopment
Cognition Corporation
软件开发
Lexington，MA 2,382 位关注者
Product development and compliance solutions to help you bring products to market faster with less risk.
关于我们
Cognition Corporation, headquartered in Lexington, Massachusetts, specializes in product development and compliance solutions for the life sciences industries. Our solutions focus on enhancing efficiency, quality, and compliance throughout the development process. For medical device companies, Cognition offers a design controls software platform, Compass MED, that helps meet regulations faster with real-time traceability, guided design controls, and change once, update everywhere functionality – turning manual and disconnected data into structured submissions that enable them to get to market faster. For pharmaceutical companies, Cognition’s Compass BIO software suite of applications for CMC module 3 reports —specifically created for pharma, biotech, and CDMO companies—is an innovative, technically driven digital CMC software solution to help biopharmaceutical companies navigate, organize, and generate the complex data tables and reports required for data management of projects and regulatory submissions without requiring manual data transcription and extensive data integrity checking. Compass BIO supports both large molecule (biologics) and traditional small molecule products. Unlike other solutions that simply replicate traditional documents and spreadsheets, Cognition takes a structured data approach so you can easily build relevant connections between data items, automatically create complex trace matrices and data tables, and export formatted documents instantly – offering a more efficient and integrated solution. We are shifting the data management landscape for life sciences product development from a static, document-based approach to a dynamic, information-driven approach helping to streamline and alleviate the administrative burden of product development documentation. Further information about Cognition Corporation can be found at www.cognition.us.
- 网站
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https://www.cognition.us
Cognition Corporation的外部链接
- 所属行业
- 软件开发
- 规模
- 51-200 人
- 总部
- Lexington，MA
- 类型
- 私人持股
- 创立
- 1996
- 领域
- Systems Engineering、Medical Device Compliance、Requirements Management、Regulatory Compliance、Design Controls、Risk Management、Use Error Analysis、Hazard Analysis、CTD/Dossier、DHF、Pharmaceutical、Traceability、Software、Test Management、Product Development、Documentation和Structured Content and Data Management
地点
Cognition Corporation员工
动态
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Are you attending the #BioITExpo in Boston next week? Stop by and say hello David Cronin. It's going to be a great event!
I will have a poster at next week's #BioITExpo in Boston, MA and hope to see some friends during the event. My poster is P18: A Product Development Platform Approach for Structured Content & Data Management (SCDM) to Feed AI/ML, Technical Reports, and Dossier Granules.
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?Only 1 Week Left! Have you reserved your spot yet? Join us next week for our highly anticipated webinar, "How Technology is Transforming the CMC Data Journey!" In just one hour, you'll learn how innovative digital solutions are revolutionizing the biopharma landscape—optimizing efficiency, improving compliance, and accelerating decision-making. Date: Wednesday, March 25, 2025 Time: 12:00PM EST Register Now: https://lnkd.in/eFhFE7jY Don't miss this opportunity to gain valuable insights from industry experts on how technology can transform your CMC data processes. #Biopharma #CMCDataJourney #DigitalTransformation #BiotechInnovation #PharmaTech #CompassBIO #PharmaQuality
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Join Our Upcoming Webinar: How Technology is Transforming the CMC Data Journey! The world of biopharma is evolving, and staying ahead of the curve means leveraging the latest technology to optimize the CMC data journey. ?? Date: Wednesday, March 26, 2025 ? Time: 12:00PM EST ?? Register Now: https://lnkd.in/ec7id486 Whether you're in product development, quality control, or regulatory affairs, this webinar is packed with insights to help you transform your approach to CMC data. #Biopharma #CMCDataJourney #DigitalTransformation #BiotechInnovation #PharmaTech #PharmaQuality
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We are thrilled to be a part of this conference! We hope to see you there!
?? Just Published! The 2025 Medical Device Safety Risk Management Conference Program ?? The conference program has been released with extensive details, showcasing an outstanding lineup of keynote speakers, expert-led sessions, and in-depth tutorials & workshops. ?? When? April 24-25, 2025 (full day of tutorials & workshops on April 23) ?? Where? Amsterdam, the Netherlands (In-person & virtual) ?? Program Highlights ? Keynotes from the FDA and TüV SüD, sharing crucial regulatory insights ? 20 expert speakers, covering the hottest topics in risk management ? 7 world-class instructors, delivering 16 hours of high-value education for just €199! ? Roundtable discussions & networking opportunities, connecting you with top industry leaders ?? Don’t Miss Out! Early Bird Discount Still Available! ?? Secure your spot now and take advantage of the reduced rate before prices go up. See the link for registration, below in the comments section. Check out the updated program & register today: see links in the comments section Join the global MedTech community in Amsterdam and be part of the future of medical device safety! ??
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We’re excited to share our latest case study on how THINK Surgical, a pioneer in robotic surgery solutions, leverages Compass MED to revolutionize their product development process. Discover how they are: ? Streamlining collaboration across teams ? Enhancing efficiency and reducing time-to-market ? Improving quality control and compliance Curious about how our solution can drive results for your business? Download the full case study here: https://lnkd.in/eTFX-Xgd #CaseStudy #ThinkSurgical #RoboticSurgery #ProductDevelopment #MedicalDevices #Efficiency #Collaboration
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Dale Gallaher and Ansgar Liening ?will be featured guests on #MDGpremium this Friday, January 24, 2025, at 8 a.m. Pacific, discussing "Bridging the Gap Between Design and Regulatory." Don’t miss out on this insightful conversation! ?? Register now: https://medgroup.biz/calls All are welcome!
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In the fast-paced world of MedTech, contract design firms are under increasing pressure to deliver complex products faster and more efficiently. That's where Compass? MED comes in! Discover 6 key benefits of Compass MED: 1?? Structured Approach: Organize every step from user needs to validation. 2?? Templates: Standardize projects with pre-built templates. 3?? Reuse: Save time by reusing data across projects. 4?? Collaboration: Collaborate seamlessly with clients and teams. 5?? Traceability: Real-time tracking for audit-ready reports. 6?? Compliance: Ensure full compliance with FDA and ISO standards. Want to know how Compass MED can help your firm thrive? Read our latest blog post. ??https://lnkd.in/e7xshE9S #MedTech #MedicalDevices #ProductDevelopment #Innovation #DesignControls #Compliance
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We are thrilled to be a part of next year's International Conference on Medical Device Safety Risk Management. Don't miss your chance to take advantage of early bird registration! We hope to see you in April in Amsterdam!
?? Don’t Miss Out! Early Bird Registration Ends December 31, 2024 ?? The 2025 International Conference on Medical Device Safety Risk Management is shaping up to be the must-attend event for MedTech professionals. https://lnkd.in/epuvRs6C Here's why you should secure your spot today: ?? World-Class Speakers: Hear from industry leaders and pioneers who are driving innovation and excellence in medical device safety. ?? Engaging Tutorials and Workshops: We’ve added a pre-conference day with hands-on tutorials and workshops, but space is limited—reserve your spot soon! ?? Cutting-Edge Program: With an incredible response to our call for abstracts, our expert panel is reviewing the submissions to craft a program that will inspire and inform. Look out for the full agenda in January! ?? Flexible Attendance Options: Can’t make it in person? Our excellent online platform ensures a seamless virtual experience. Plus, all registered delegates will receive access to conference recording post-event. This conference is more than just an event—it’s an opportunity to connect with top experts, share knowledge, and advance your career while contributing to the progress of MedTech safety. ?? When: 24-25 April 2025 (pre-conference workshops: 23 April 2025) ?? Where: Amsterdam, the Netherlands, and virtually worldwide Register now and secure the early bird discount before December 31, 2024!? ?? https://lnkd.in/eeZ45_eE Let’s advance MedTech safety—together. See you in Amsterdam! #MedicalDeviceSafety #RiskManagement #MedTechConference
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In the world of medical device development, manufacturers face a range of concerns: How can we increase efficiencies and get to market faster? How can we ensure quality and safety? How can we enhance compliance and reduce risks? Now, imagine a structured data management and design control SaaS solution that is purpose-built to address every one of these concerns, and more. You don’t have to imagine it — because it’s here. Watch our short video to learn more about Compass MED.