MEDIcept Inc.

Happy Independence Day from MEDIcept Inc.! #IndependenceDay #FourthOfJuly #Celebrate

Hot News: Revised Version of the MDCG Guidance on Standardisation for Medical Devices, Now Available! Exciting news! The revised and improved version of the MDCG guidance document "MDCG 2021-5 Rev.1 - Guidance on standardisation for medical devices - July 2024" has been officially endorsed by the MDCG and is now accessible on the European Commission EU Health and Food Safety DG SANTE webpage. This updated version includes new sections on the rulings of the Court of Justice of the European Union, the European Pharmacopoeia, and Common Specifications, offering a comprehensive reference on various aspects of standardisation in support of EU Regulations on Medical Devices (MDR) and In Vitro Diagnostic Medical Devices (IVDR). For detailed insights and practical guidance, check out the document directly via the link below. https://lnkd.in/dFZQMK5Y For further information and assistance, contact MEDIcept at [email protected] for expert support and guidance in navigating the standards landscape in the medical devices sector. #MDCG #Standards #MedicalDevices #EU #Regulations #MDR #IVDR #Standardisation #EuropeanCommission #Healthcare #Guidance #MedTech 

MEDIcept Minute: Upcoming Medical Device Sterilization Town Hall from FDA: Mock Pre-Submission on Implementing a Change in Sterilization Method – July 10th! Join the U.S. Food and Drug Administration (FDA) on July 10, 2024, for the Medical Device Sterilization Town Hall: Mock Pre-Submission on Implementing a Change in Sterilization Method. This virtual event will feature a mock pre-submission for a fictional medical device, offering insights into the regulatory, design, and testing considerations involved in changing sterilization methods. The town hall will run from 1:00 to 2:30 PM ET, and registration is not required to attend. This is a great opportunity to deepen your understanding of medical device sterilization processes and explore the FDA's multipronged approach to ensuring the integrity of the supply chain while reducing reliance on ethylene oxide sterilization. For more information and to join the town hall, click the link below. https://lnkd.in/ezPGXyWK Need assistance with medical device sterilization or navigating regulatory requirements? Contact MEDIcept Inc. for expert guidance and support in ensuring your medical devices meet the highest standards. Email us at [email protected] to learn more about how we can help. #MedicalDevice #Sterilization #FDA #RegulatoryAffairs #MedicalDeviceSterilization  

MEDIcept Employee Spotlight: Gregg Van Citters  We're excited to shine the spotlight on one of our invaluable team members at MEDIcept Inc., Gregg V., Senior Software Quality Engineer! Gregg's proficiency in software quality and cybersecurity is unmatched. He consistently delivers exceptional service to clients, leveraging his vast experience and expertise. His capability to tackle complex cybersecurity issues and seamlessly integrate solutions into our quality management systems sets a high bar in the industry. A recent project highlights Gregg's outstanding contributions. He developed an insightful presentation titled "Integrating Medical Device Cybersecurity in the Quality Management System." This 45-minute session, initially presented during a Lunch-n-Learn at MEDIcept and then at the recent RAPS conference in Berlin, was so impactful that it was turned into a podcast, now available to our clients via our YouTube channel. Gregg's thorough and engaging delivery ensured that crucial information reached and benefited a broader audience. Gregg's dedication and expertise have earned commendation from our clients. For instance, a recent client recently expressed their gratitude for Gregg's cybersecurity knowledge. During a meeting with this client’s representative, we were delighted to hear that they had recently watched Gregg's podcast on cybersecurity. They mentioned that the insights from Gregg's presentation played a critical role in shaping their next steps for integrating cybersecurity into their product line. Gregg's commitment to excellence and client satisfaction exemplifies the high standards of talent we have at MEDIcept. Join us in celebrating his remarkable contributions! Email us today at [email protected] to discover how Gregg and the rest of our QE-SQE team can support your needs. #EmployeeSpotlight #QualityEngineering #CyberSecurity #Innovation #TeamSuccess 

MEDIcept White Paper: Risk Management Series – Part 2: Using Fault Trees to Focus and Simplify Risk Analysis Dive into Part 2 of our Risk Management Series, where we explore the transformative potential of Fault Tree Analysis (FTA) for medical devices. Discover how FTA offers a comprehensive, top-down approach to hazard identification, bridging the gap that traditional FMEA processes often leave. Learn how this method not only simplifies risk analysis but also enhances communication and understanding among your team.  Join authors Brian Siroka, Associate Consultant, and Gregg V., Sr. Software Quality Engineer, as they explore the intricacies of FTA and provide actionable insights to bolster your risk management strategy. Access the White Paper by clicking the link below.  https://lnkd.in/eUxHTYGu Want to elevate your risk management processes? Contact MEDIcept Inc. today at [email protected] to learn how we can help you achieve comprehensive and effective risk analysis.  #MedicalDevices #FTA #FMEA #RiskManagement #RiskAnalysis #Quality #WhitePaper

Hot News: FDA Issues Small Entity Compliance Guide for Laboratory Developed Tests! Exciting update from the FDA's Center for Devices and Radiological Health! The FDA has issued a Small Entity Compliance Guide (SECG) to help small entities navigate the new regulations for in vitro diagnostic (IVD) products, including laboratory developed tests (LDTs). The LDT final rule, effective May 6, 2024, clarifies that IVDs are considered devices under the FD&C Act, even when manufactured by laboratories. Over the next four years, the FDA will phase out its general enforcement discretion approach for LDTs, ensuring uniform enforcement for all IVDs. This guide provides crucial information on the scope, timing, and compliance expectations for these new regulations. Click below for more information on this guide. https://lnkd.in/g-FWjQct Need assistance navigating these changes? Contact MEDIcept Inc. today at [email protected] for expert guidance! #LDTs #IVDs #MedicalDevices #FDA 

That’s a wrap on the 2024 MedTech MVP Venture and Partnering Confefence! ☑️ Our team enjoyed chatting with so many of you. If you didn’t get a chance to connect, email us at [email protected] to set up a meeting to learn more about our capabilities. #MedTech #MedicalDevices #Venture #Partnering #Quality #Regulatory #ClinicalTrials

Hot News: Upcoming FDA Webinar - Overview of In Vitro Diagnostic (IVD) Product Classification – July 16th! Attention all medical device professionals! The U.S. Food and Drug Administration (FDA) will be hosting a webinar on July 16, 2024, from 1:00 PM to 2:00 PM EST to discuss the classification of in vitro diagnostic (IVD) products.  This session is crucial for professionals in the medical device industry to gain a better understanding of the FDA's classification system for IVDs, which are essential tools used in diagnosing diseases and health conditions. The webinar will cover how IVDs are classified into Class I, II, or III, based on the level of regulatory control required to ensure safety and effectiveness. Attendees will learn about the impact of these classifications on the premarket process and post-market controls.  Questions for the webinar must be submitted by June 28, 2024, to [email protected]. Click the link below to learn more about this webinar and how to attend. https://lnkd.in/eht6VzM6 Don't miss this opportunity to stay informed about FDA regulations and ensure compliance with industry standards! For expert assistance with your IVD needs, contact MEDIcept Inc. today at [email protected]! #FDA #Webinar #LDT #IVD #InVitroDiagnostics #MedicalDevices

MEDIcept Minute: Just Released - Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles! Exciting news in the realm of AI and healthcare! The FDA, Health Canada, and the UK's MHRA have jointly released a new document outlining guiding principles for transparency in machine learning-enabled medical devices (MLMDs). Building on the 2021 Good Machine Learning Practice (GMLP) principles, these new guidelines, released June 13th, 2024, emphasize the importance of clear communication and user-focused design. Key highlights include building upon the GMLP principles, especially:  -Principle 7: Enhancing the human-AI team performance.  -Principle 9: Providing users with clear, essential information. Transparency in MLMDs ensures that relevant information about a device’s use, development, and performance is accessible, fostering trust and enhancing patient outcomes. Dive into the details at the link below and see how these principles can drive innovation and safety in medical device technology. https://lnkd.in/eNQJfZgD For expert guidance and support with your MLMD needs, contact MEDIcept Inc. today at [email protected]. #HealthTech #AI #MachineLearning #MedicalDevices #Innovation #ArtificialInteligence

We are excited to unveil our new LinkedIn banner that encapsulates the essence of our comprehensive medical device consulting service offerings! This banner highlights our five service lines: Clinical Trials, Regulatory Affairs, Quality Management Services, Quality Engineering and Reimbursement & Compliance. As a global full-service Clinical Research Organization (CRO), we provide expert guidance and support throughout the clinical trial process. Our regulatory team ensures compliance and smooth navigation through complex regulatory landscapes. Quality management is at the core of our operations, emphasizing excellence and continuous improvement. Our quality engineering solutions, which include advanced cybersecurity measures and AI integration, enhance product reliability and performance. Lastly, our reimbursement and compliance services help clients maximize their return on investment. Interested in exploring how we can assist you in achieving success in the medical device industry? Contact MEDIcept Inc. at [email protected] to get started. #MedicalDevices #Clinical #Regulatory #QMS #QualityEngineering #Reimbursement #PageUpdate