NAMSA

📢 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📢 Join Our Upcoming Webinar: Understanding the New FDA Draft Guidance for Chemical Characterization 📢 🗓️ Date: October 9, 2024 🕙 Time: 10:00 AM - 11:00 AM CT The FDA's highly anticipated new draft guidance on chemical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

🔒 At NAMSA, we understand the importance of data integrity and security in today's medical device industry. With recent FDA notices and concerns over data protection, it's clear that trust is more crucial than ever. We're proud to be the only fully ASCA-accredited Biocompatibility lab, showcasing our commitment to quality testing. Don't let the industry's uncertainties shake your confidence. Partner with NAMSA, where safeguarding your data is part of our DNA. Let's discuss how we can support your success and keep your sensitive information secure. 🛡️ https://lnkd.in/gUfCPbui #DataSecurity #NAMSATrust #MedicalDeviceTesting

🚀 We're thrilled to share Episode 14 of the MedTech Matters Series: "Opportunities to Accelerate Clinical Research Through Outpatient Site Networks." In this episode, we dive into the world of clinical research and explore how Office-Based Labs (OBLs) and Ambulatory Surgery Centers (ASCs) are revolutionizing the field. Discover the unique advantages these settings offer for conducting clinical trials efficiently and effectively. Our special guest, Sara Vidmar, brings a wealth of knowledge to the table. With her experience as NAMSA's former Vice President of Global Clinical Services and her current role at Alleviant Medical, she sheds light on the potential these outpatient networks hold for accelerating medical advancements. Don't miss out on this opportunity to learn from one of the industry's leading experts! 📺 Tune in now and stay ahead in the fast-paced world of medical technology! https://lnkd.in/g4mjcejK #MedTech #ClinicalResearch #NAMSAKnows #OutpatientNetworks #HealthcareInnovation