NAMSA’s Post

🔬 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

🔬 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

What’s a Notified Body? And Why Should IVD Companies Care? If you’re in the world of in vitro diagnostics (IVDs), you’ve probably heard the term “Notified Body” tossed around. But what does it really mean, and why is it so important? Let us at Sertio Oy, a Notified Body under the IVDR, break it down for you! What’s a Notified Body? In simple terms, a Notified Body is an independent organization that the EU has designated to assess whether certain products—like your IVD devices—meet the strict regulatory requirements laid out by the In Vitro Diagnostic Regulation (IVDR). Think of us as the gatekeepers who ensure that only safe, high-quality devices make it to the market. What Does Sertio Oy Do as a Notified Body? 1. Independent Assessors: We’re here to objectively evaluate your IVD device. Our role is to rigorously assess your documentation, performance data, and all the technical evidence you provide to ensure your product meets the IVDR’s standards. No shortcuts, just a thorough, unbiased review. 2. CE Mark Certifiers: If your IVD device checks all the boxes, we issue the CE certification you need to sell your product in the EU. This mark is your ticket to the market, signaling that your device is compliant, safe, and ready for use. 3. Ongoing Compliance Partners: Our job doesn’t stop once the certification is issued. We continue to monitor your device through post-market surveillance, ensuring it remains compliant with the IVDR throughout its lifecycle. Why Should You Care? For IVD companies, partnering with a Notified Body like Sertio Oy isn’t just a regulatory requirement—it’s a critical step in making sure your product is safe, effective, and ready to meet the demands of the EU market. Without our assessment and certification, your IVD device simply can’t be legally sold in the EU. So, when you think “Notified Body,” think of Sertio Oy—your trusted partner in navigating the IVDR and bringing top-quality IVD devices to the market. Ready for your assessment? Reach out to Sertio Oy, and let’s make sure your IVD device is compliant, certified, and ready to go! #IVDR #NotifiedBody #InVitroDiagnostics #Compliance #RegulatoryAffairs #SertioOy #IVD #CECertification

As we continue our series on the LDT Final Rule, it’s time to turn our attention to the IVD (In Vitro Diagnostics) manufacturers. The new regulations bring significant changes that could impact turnaround times for FDA reviews and pose compliance challenges. But don't worry – with proactive strategies, IVD manufacturers can navigate these changes effectively. In our latest post, we discuss the specific impacts on IVD manufacturers and provide practical advice for managing potential delays and ensuring compliance. 🔍 Key Highlights: Turnaround Time Concerns Understanding the Impact on Review Processes Strategies for Managing Delays Compliance Challenges Adapting to New Regulatory Requirements Implementing Effective Compliance Strategies 👉 Read the full article on our blog: https://lnkd.in/gurKSyUc Stay tuned for our next post where we will explore the impacts of the LDT Final Rule on RUO manufacturers and provide guidance on adapting to the new limitations and submission requirements. #IVDManufacturers #LDTFinalRule #FDACompliance

Helping US IVD Clients Seamlessly Transition from LDT to IVD In the fast-evolving landscape of diagnostics, the shift from Laboratory Developed Tests (LDTs) to In Vitro Diagnostics (IVDs) presents a unique set of challenges for companies in the US. Whether it's navigating new FDA regulations, ensuring compliance, or implementing the right quality and regulatory frameworks, this transition demands specialized expertise. At Arevna, we understand the complexities of this change and are here to support your journey. Our extensive experience in providing top-tier QARA professionals has helped clients throughout the US successfully transition from LDT to IVD. How We Can Help You: Tailored Talent Solutions: Whether you need permanent staff or contract professionals, we have an exceptional pool of specialists with expertise in FDA regulations, IVDR, clinical validation, and quality systems. Proven Track Record: We’ve worked with some of the leading IVD companies across the US, helping them streamline processes, meet compliance deadlines, and achieve regulatory approvals without disruption. End-to-End Support: From regulatory affairs to quality assurance, our professionals are skilled in managing the entire transition process, ensuring your team is equipped to thrive in this new regulatory environment. If you’re looking for experienced QARA professionals to support your LDT to IVD transition, reach out to us today! Let us help you stay ahead of regulatory changes while maintaining the highest standards of compliance. Contact us today to discuss how we can partner with you!

Listen back to our “Understanding and meeting the EU IVDR requirements for In Vitro Diagnostics (IVD) Kits” webinar, presented by Alex Laan, Head of Notified Body – IVD and Sara Fabi, Regulatory Lead, Notified Body – IVD. The webinar presents a brief overview of definitions of IVD kits, accessories, components, and procedure packs. Our speakers discuss qualification and classification as well as regulatory requirements of IVD kits in addition to product configurations and potential certification scenarios. Access the recording and slides, here: https://gag.gl/4Fnl4n #BSI #MedicalDevices #IVDR #IVDKits #RegulatoryCompliance

Listen back to our “Understanding and meeting the EU IVDR requirements for In Vitro Diagnostics (IVD) Kits” webinar, presented by Alex Laan, Head of Notified Body – IVD and Sara Fabi, Regulatory Lead, Notified Body – IVD. The webinar presents a brief overview of definitions of IVD kits, accessories, components, and procedure packs. Our speakers discuss qualification and classification as well as regulatory requirements of IVD kits in addition to product configurations and potential certification scenarios. Access the recording and slides, here: https://gag.gl/4Fnl4n #BSI #MedicalDevices #IVDR #IVDKits #RegulatoryCompliance

Is it a bird? a plane? or a kit? I've been a part of so many projects where it was unclear if we were dealing with a procedure pack, kit, accessory, convenience kit or a device. Many companies get these definitions wrong when they first start out, and it doesn't help that the FDA has slightly different definitions than the EU. Having the correct definition also has an impact on labeling, including UDI. This webinar looks like a great resource! #IVD, #IVDR, #Regulatory #CEIVD #Quality #LDT

Listen back to our “Understanding and meeting the EU IVDR requirements for In Vitro Diagnostics (IVD) Kits” webinar, presented by Alex Laan, Head of Notified Body – IVD and Sara Fabi, Regulatory Lead, Notified Body – IVD. The webinar presents a brief overview of definitions of IVD kits, accessories, components, and procedure packs. Our speakers discuss qualification and classification as well as regulatory requirements of IVD kits in addition to product configurations and potential certification scenarios. Access the recording and slides, here: https://gag.gl/4Fnl4n #BSI #MedicalDevices #IVDR #IVDKits #RegulatoryCompliance

While the recent FDA Final Rule related to In Vitro Diagnostics and Laboratory Developed Tests has sparked concerns around enforcement risk, cost, and compliance burden for manufacturers, in our latest whitepaper we also highlight the hidden market access opportunities for IVD developers that are quick to adapt. Our experts Nayan Ghosh & Emma Feinerman draw parallels to a similar guidance around in vitro companion diagnostics released a decade prior, when companies like Foundation Medicine & QIAGEN saw favorable, product-specific coverage determinations by proactively pursuing FDA premarket review ahead of their LDT competitors. Request a full copy here: https://lnkd.in/eptbRN73