NAMSA

Join us at the Greenberg Stent Summit on September 5th, 2024, where NAMSA's experts will share their insights. Dr. Kenneth Ouriel will address the question "Are there certain types of studies/approaches that yield better compliance?" offering his seasoned perspective on enhancing study outcomes. Deborah Mange will discuss the "Importance of hospital infrastructure in supporting clinical studies," providing valuable knowledge for healthcare professionals. Looking forward to seeing you there for a day of thoughtful dialogue and learning! #GreenbergStentSummit2024 #ClinicalResearch #HealthcareInnovation #NAMSASpeakers

🔬 Explore the Power of Hemolysis Testing with NAMSA! 💉 Discover our recent blog post highlighting the Mechanical Hemolysis Assay performed at our Minneapolis lab. This vital in-vitro test, based on ASTM F1830 and F1841 guidelines, assesses the hemolytic potential of blood-contacting test articles compared to predicate devices. 👩🔬Learn how this adaptable test can benefit various device types and why it's FDA-recommended for assessing blood-contacting devices. Read the full article here 👉 https://lnkd.in/ea3XqGsX #HemolysisTesting #MedicalDevices #FDARecommended #NAMSAKnows

📢 Stay ahead with our latest blog: "MDCG 2024-2: Navigating the New Updates to the European Medical Device Nomenclature." Discover the essential processes for annual and ad-hoc EMDN updates that could impact your compliance strategy. 🛠️ Dive into the roles of the MDCG Working Group, and EMDN Technical Team, and how user feedback shapes the nomenclature. Plus, get expert insights on what these changes mean for manufacturers, especially those with novel devices. Don't miss out on these critical updates – Read now! 👉 https://lnkd.in/gghEwNye #MedicalDevices #EMDN #RegulatoryAffairs #MDCG2024 #Compliance #NAMSAKnows

🎧 Dive into the latest RAQA Cafe Episode 12: "Risk Management, Clinical Evidence and Post-Market Reporting" for a masterclass in medical device regulations. Dr. Beatriz Rodriguez Grande and Dr. Sean Bird from NAMSA's Medical Writing team share their expertise on creating robust documentation that meets regulatory standards. Learn how to effectively manage risk, gather clinical evidence and handle post-market surveillance. This episode is packed with actionable advice, including tailoring documentation for your audience, coordinating information seamlessly and demonstrating compliance through data-backed evidence. Whether you're in the industry or just interested in the field, this conversation is a must-listen! Listen to the full episode now >> https://lnkd.in/g-Kz_3yf #RAQACafe #MedicalDevices #RegulatoryExcellence #NAMSAGlobal

📢 Upcoming Webinar: AI/ML SaMDs Medical Devices: New and Unique Challenges in Getting to Market 📢 Join our webinar on the FDA approval process for Software as a Medical Device (SaMD). Learn from industry experts about SaMD-specific regulations and how to market your product effectively. Perfect for both startups and established firms, gain strategies to overcome typical hurdles in the digital health industry. 📅 Date: September 25th, 2024 🕙 Time: 10:00 AM - 11:00 AM CT Learning Points: 1️⃣ FDA's AI/ML Action Plan: ◾️Understand SaMD regulatory requirements. ◾️Overview of FDA's approach to SaMD regulation. 2️⃣ The Good Machine Learning Practices Model: ◾️Importance of clinical evidence for approval. ◾️Designing and conducting SaMD clinical studies. ◾️Required data and documentation for safety and efficacy. 3️⃣ SaMD Data Collection Challenges: ◾️Ensuring cybersecurity best practices. ◾️FDA expectations for data privacy. ◾️Implementing security for patient information protection. Speakers: Adam Saltman Principal Strategy Consultant, Clinical and Regulatory Services Monica Montanez MS RS RAC CQA Principal Strategy Consultant, Regulatory 🔗 Register https://lnkd.in/gyZZ_vYX Don't miss out on this opportunity to stay ahead in the competitive digital health landscape! #softwareasamedicaldevice #samd #artificialintelligencemachinelearning #aiml #NAMSAKnows

Check out our recent blog post on taking a medical device from initial idea to finalized product. It's a challenging process, but with the right help, it becomes much easier to understand. The blog covers important steps like understanding market competition, classifying your device correctly, conducting necessary testing and navigating premarket submissions. Don't miss out on valuable insights and tips for successful medical device commercialization https://lnkd.in/gJF-m4JB #medicaldevices #medtech #commercialization

🌐 Enhance your clinical narrative with NAMSA's Medical Writing Services! 🚀💡 Join our journey for easy regulatory compliance and fast commercialization with NAMSA's esteemed Medical Writing Team. 🚀 Key Features: 1️⃣ Proven Expertise: 20+ medical writing experts from a diverse range of clinical and scientific backgrounds, of whom almost half hold doctorates. 2️⃣ Global Reach: Effectively communicate your narrative in 8 languages, ensuring a broad approach to diverse regulatory guidelines. 3️⃣ Regulatory Compliance: Master the complexities of various regulations like MDR, IVDR, MEDDEV 2.7.1 rev. 4, NMPA, and more. 4️⃣ Comprehensive Services: ◾️MDR Clinical Evaluation Plans & Reports ◾️IVDR Performance Evaluation Plans & Reports ◾️Systematic Literature Reviews & Meta-Analyses ◾️Clinical Study Reports & Annual Progress Reports ◾️Scientific Publications & Conference ◾️Abstracts Summaries of Safety & Clinical Performance ◾️Investigator Brochures ◾️Labeling, Instructions for Use, User Manuals ◾️Safety Update Reports and Post-Market Surveillance Reports ◾️Implant Cards 🔗 Discover our all-inclusive Medical Writing Services and write your medical device's success story! https://lnkd.in/gBu7JpRr #MedicalWriting #ClinicalData #RegulatoryCompliance #NAMSAKnows #CommercializationSuccess

📣 Industry professionals, take note! The FDA's new Quality Management System Regulation (QMSR) is here, incorporating ISO 13485:2016 standards. This pivotal update aims to streamline processes for medical device manufacturers while upholding product safety and efficacy. 👉 Stay informed and ready for the 2026 compliance deadline. For a deep dive into the QMSR and its implications, check out our latest blog post. 🔗 https://lnkd.in/gYwM72V6 for insights and guidance on navigating these changes. #QMSR #FDA #MedicalDevices #ISO13485 #Compliance #NAMSAKnows

Discover the Three Essentials for a Stellar Clinical Study Report! The Clinical Study Report (CSR) is an indispensable document in the journey of medical device development. 📄 It encapsulates the background, methods, results, and conclusions from a clinical study of a medical device. To craft an impactful CSR, focus on these three pillars: 1. Accuracy - Ensure every detail is precise, communication is crystal clear, and data is meticulously cross-checked. ✅ 2. Narrative Cohesion - Weave a coherent story to maintain clarity throughout the report. 📖 3. Cross-Functional Expertise - Draw on diverse knowledge to create a quality document that adheres to regulatory standards. 🤝 👉 Dive deeper into our insights! Read the full blog at https://lnkd.in/g3cbKfcv and elevate your CSR today! 📚 #ClinicalTrials #RegulatoryCompliance #MedicalWriting #NAMSAKnows

The U.S. Food and Drug Administration (FDA), Health Canada and the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) have jointly published the "Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles." This document encourages international harmonization and outlines five guiding principles for PCCPs. Access NAMSA's blog post to learn more about how these guiding principles impact medical device developers: https://lnkd.in/djiFK67j #MedTech #MedicalDevices #FDAguidelines #machinelearning