NAMSA

🔬 Navigating IVD product challenges with NAMSA 🔬 Embark on a journey of seamless IVD device approvals with NAMSA! 🚀 Our In Vitro Diagnostics team transforms complex regulatory and clinical challenges into streamlined strategies, ensuring top-tier product quality, compliance and clinical trials. Understanding the unique nature of IVD devices from specimen management to importing instrument data and clear technical file reports - trust NAMSA has the experts to support the unique needs of your IVD device across multiple diagnostic areas and user environments. Here's why you should choose NAMSA: ✨ Key Stats -Supported 200+ global IVD studies 🌍 -Managed 500+ IVD trial sites 🏥 -Submitted 170+ global regulatory submissions 📑 Why NAMSA for IVD? Our experts simplify the path to market approval for life-changing IVD products. From regulatory assessments to clinical trials and quality systems, we cover it all. Partner with the most flexible IVD CRO in the industry — your success is our commitment. Ready to elevate your IVD journey? Contact us now! https://lnkd.in/gMsv5hsd 🌐✉️ #IVD #RegulatoryCompliance #ClinicalTrials #NAMSAKnows

📢 Join Our Upcoming Webinar: Understanding the New FDA Draft Guidance for Chemical Characterization 📢 🗓️ Date: October 9, 2024 🕙 Time: 10:00 AM - 11:00 AM CT The FDA's highly anticipated new draft guidance on chemical characterization is here! This webinar is a must-attend for industry professionals looking to understand the FDA's expectations and navigate these changes effectively. Key Takeaways: 🔍 Understanding the New Requirements: Gain a comprehensive overview of the new FDA guidance and its implications for your organization. 🛠️ Best Practices for Compliance: Learn practical strategies to ensure your chemical characterization processes meet the new standards. Don't miss this opportunity to stay informed and ensure your organization is prepared for the new regulatory landscape. https://lnkd.in/g9gJNvB3 to secure your spot! #FDA #ChemicalCharacterization #NAMSA #Webinar #RegulatoryCompliance

📢 NAMSA Blog: What is the difference between SiMD and SaMD? 📢 The World Health Organization (WHO) estimates around 2 million medical devices exist, categorized into over 7,000 groups. These devices diagnose illnesses and assist disabled individuals. With IoT and tech advancements, software is now crucial in medical devices. Key Highlights: -SaMD (Software as a Medical Device): Independent software providing medical benefits, posing risks if it malfunctions. Example: Software for viewing MRI images on smartphones. -SiMD (Software in a Medical Device): Software supporting medical device hardware. Example: Software powering devices or processing their data. Why It Matters: -Improved Health Outcomes: SaMD collects high-quality data, improving health outcomes. -Faster Innovation: SaMD enables quicker product iterations and market entry. For a deeper dive into the differences between SiMD and SaMD, read our latest blog: https://lnkd.in/gitXnAHr #MedicalDevices #SaMD #SiMD #HealthcareInnovation #NAMSAKnows

Check out the latest Project Medtech Podcast episode featuring NAMSA's own Don Pohl and Sheri Krajewski! 🎙️ They dive into ISO 10993, biocompatibility testing, and share valuable insights on navigating regulatory submissions. Don't miss their expert tips and discussions on the evolving standards in the medtech industry. #medicaldevices #medtech #innovation #podcast #strategy

Tune in to NAMSA's episode of the BiocompCHATibility podcast, where our hosts, joined by Dr. Phillip Smiraldo (NAMSA Senior Toxicologist), discuss the recently published FDA biocompatibility guidance. Listen now to learn about how the updated terminology impacts marketing, how to best utilize the addition of the new appendix and more: https://lnkd.in/gQB8JAZB. #medtech #medicaldevices #FDA #biocompatibility

📢 SAVE THE DATE 📢 Looking to optimize the commercial success of your medical devices by ensuring regulatory compliance while remaining agile and pragmatic? 👉 Join our webinar, ISO13485 and MDR 2017/745: How to Make Your QMS Compliant with the Requirements?, jointly organized by ARIAQ SA - Formation et Conseil en Qualité et Performance and 𝗡𝗔𝗠𝗦𝗔. This session will guide you through integrating the requirements of the regulation (𝗘𝗨) 𝗠𝗗𝗥 𝟮𝟬𝟭𝟳/𝟳𝟰𝟱 and the 𝗜𝗦𝗢 𝟭𝟯𝟰𝟴𝟱 standard into your Quality Management System. 📢 Webinar Language: French 🔗 Register now to secure your spot! https://lnkd.in/errEYaK5

📢 Join Our Upcoming Webinar: Understanding the New FDA Draft Guidance for Chemical Characterization 📢 🗓️ Date: October 9, 2024 🕙 Time: 10:00 AM - 11:00 AM CT The FDA's highly anticipated new draft guidance on chemical characterization is here! This webinar is a must-attend for industry professionals looking to understand the FDA's expectations and navigate these changes effectively. Key Takeaways: 🔍 Understanding the New Requirements: Gain a comprehensive overview of the new FDA guidance and its implications for your organization. 🛠️ Best Practices for Compliance: Learn practical strategies to ensure your chemical characterization processes meet the new standards. Don't miss this opportunity to stay informed and ensure your organization is prepared for the new regulatory landscape. https://lnkd.in/g9gJNvB3 to secure your spot! #FDA #ChemicalCharacterization #NAMSA #Webinar #RegulatoryCompliance

📢 Upcoming Webinar: AI/ML SaMDs: Cybersecurity, Human Factors, and Privacy 📢 📅 Date: November 12, 2024 🕙 Time: 10:00 AM - 11:00 AM CT 🌐 Register Now: https://lnkd.in/gWNckYpe This webinar explores cybersecurity, human factors, and privacy for AI/ML SaMDs, also known as Machine Learning Enabled Medical Devices (MLEMDs), which use technologies like wireless connectivity, software as a service, and mobile platforms. Key Learning Points: ◾️ FDA's views on privacy, cybersecurity, and wireless coexistence ◾️ The CFR, GDPR, and HIPAA ◾️ Designing your product before clinical trials ◾️ Meeting FDA's human factors/usability testing requirements for AI/ML SaMDs Join us to stay ahead in the rapidly evolving digital health landscape! #MedicalDevices #HealthcareInnovation #NAMSAKnows #SaMD #AI #MLEMD

🔬 Breaking News for In Vitro Diagnostic Manufacturers! 📣 The European regulatory landscape is ever-evolving, and staying ahead of the curve is essential for your success. With the expert panels now operational and just a few days to go before the EURL designation comes into force (October 1, 2024), the Medical Device Coordination Group (MDCG) has just released a revised version of MDCG 2021-4, a comprehensive guideline about the application of transitional provisions for certification of Class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746. This new revision­­–including minor amendments throughout the document as well as an additional question­­–is a must-read for Class D IVD manufacturers. 💡 At NAMSA, we understand these challenges and are poised to be your partner in turning them into opportunities for growth and innovation. Our clinical and regulatory experts will guide you through the new challenges, ensuring precision and alignment with the IVDR. https://lnkd.in/gBNaVNE7

📢 Upcoming Webinar: AI/ML SaMDs: Cybersecurity, Human Factors, and Privacy 📢 🗓 Date: November 12, 2024 🕙 Time: 10:00 AM - 11:00 AM CT 🌐 Register Now: This webinar explores cybersecurity, human factors, and privacy for AI/ML SaMDs, also known as Machine Learning Enabled Medical Devices (MLEMDs), which use technologies like wireless connectivity, software as a service, and mobile platforms. Key Learning Points: FDA’s views on privacy, cybersecurity, and wireless coexistence The CFR, GDPR, and HIPAA Designing your product before clinical trials Meeting FDA’s human factors/usability testing requirements for AI/ML SaMDs Join us to stay ahead in the rapidly evolving digital health landscape! #MedicalDevices #HealthcareInnovation #NAMSAKnows #SaMD #AI #MLEMD