NAMSA’s Post

Conducting a risk-benefit assessment for your medical device is a crucial component of the clinical evaluation process, ensuring patient safety, Regulatory compliance, and effective lifecycle management. Moreover, documenting the analysis in the CER is an important task that you must undertake. To get a thorough understanding of risk-benefit analysis in the context of CERs, PMS, and PMCF activities, read our whitepaper! https://lnkd.in/dwrP5WkA #RiskAssessment #PatientSafety #ClinicalEvaluationReport #RegulatoryCompliance #Marketplace #DataCollection #ClinicalEvidence #LifecycleManagement #Whitepaper #Freyr

Conducting a risk-benefit assessment for your medical device is not just a checkbox in the clinical evaluation process. It's a critical step that can safeguard patient safety, ensure regulatory compliance, and lay the foundation for effective lifecycle management. 🏥💡 And here's the key: documenting this analysis in your Clinical Evaluation Report (CER) is not just important; it's a MUST! 📝

The FDA has taken decisive action to enhance the oversight of laboratory developed tests (LDTs), crucial diagnostic tools increasingly integrated into healthcare decisions. With a finalized rule aligning LDTs with medical device standards under the FD&C Act, the FDA aims to phase out its previous enforcement discretion approach over the next four years. This move addresses longstanding regulatory gaps, acknowledging the evolving complexity and risks associated with modern LDTs, which were previously not subject to FDA approval. The agency's efforts underscore a commitment to ensuring the accuracy and effectiveness of diagnostic tests, crucial for informed healthcare decisions. Through targeted enforcement discretion policies and mandates under the FD&C Act, the FDA seeks to strike a balance between safety and accessibility in diagnostic testing. This regulatory framework encompasses premarket review, quality standards, adverse event reporting, and labeling requirements, bolstering confidence among patients and healthcare providers. These measures highlight the FDA's dedication to fostering trust in diagnostic testing while safeguarding patient well-being in an ever-evolving healthcare landscape. #FDARegulation #DiagnosticTesting #HealthcareSafety #MedicalDeviceStandards #LDTs #FDAOversight #HealthcareQuality #PatientSafety #HealthcareTrust #MedicalDevices #FDACompliance #HealthcareDecisions #RegulatoryUpdates #InformedHealthcare #FDAApproval Link to Article:https://lnkd.in/eP4aw-ux

As the life sciences industry adapts to significant regulatory changes, recent extensions to MDR deadlines bring both relief and unforeseen challenges. 🤔 It is essential to understand the urgent need for action, as the consequences extend beyond individual manufacturers and affect the entire system. ✔️ In our latest article, you can learn key insights to meet the extended MDR/IVDR compliance deadlines in time and ensure your device's market access and patient safety. Ready to anticipate the Notified Body rush? Read more here: 👇 https://hubs.li/Q02g6t5x0 #RegulatoryCompliance #MDR #IVDR #LifeSciences #NotifiedBody

Earlier this year Marcus Torr, Martha Vakalopoulou-Paschalidou, Tonika Chester, Tom Melvin and I wrote an article published in the JMDR 📄𝐏𝐥𝐚𝐧𝐧𝐢𝐧𝐠, 𝐝𝐞𝐬𝐢𝐠𝐧𝐢𝐧𝐠 𝐚𝐧𝐝 𝐢𝐦𝐩𝐥𝐞𝐦𝐞𝐧𝐭𝐢𝐧𝐠 𝐡𝐢𝐠𝐡-𝐪𝐮𝐚𝐥𝐢𝐭𝐲 (𝐋𝐞𝐯𝐞𝐥 4) 𝐩𝐨𝐬𝐭-𝐦𝐚𝐫𝐤𝐞𝐭 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐟𝐨𝐥𝐥𝐨𝐰-𝐮𝐩 𝐬𝐮𝐫𝐯𝐞𝐲𝐬📄 This article is now 𝐟𝐫𝐞𝐞 𝐟𝐨𝐫 𝐚𝐥𝐥, and can be seen below. Give the article a read and feel free to reach out if you have any questions on how you can leverage high-quality surveys to collect compliant clinical data for your MDR submissions. #eumdr #pmcf #mdr #JMDR #pmcfsurveys

👀Sneak Preview JMDR November 2023 issue: 💥"Planning, designing and implementing high-quality (Level 4) post-market clinical follow-up surveys" Since the implementation of the European Medical Device Regulation (MDR), device manufacturers are required to be more proactive in assessing the safety and performance of their products, backing this up with clinical data and post-market monitoring. The data collected are then used to update risk management and the clinical evaluation of each device. Post-market clinical follow-up (PMCF) surveys have become a hot topic across the industry, as they offer a cost-effective solution for PMCF data collection, albeit implementing them effectively can be troublesome. This article by Marcus Torr, Martha Vakalopoulou-Paschalidou, Tonika Chester, Chris Webb and Tom Melvin focuses on high-quality, case/patient specific PMCF surveys, providing Level 4 data, and outlining how to plan, design and implement these for successful submission to the Notified Bodies and for MDR certification. Subscribe now to read the full story: 👉 https://lnkd.in/dCyF49rt #medicaldevices #dispositivimedici #dispositivosmedicos #dispositifsmedicaux #medizinprodukte #regulatoryaffairs #pmcf #eumdr

At NAMSA, our experts provide valuable insights and recommendations to ensure your Clinical Evaluation Reports (CERs) meet MDR requirements. Don’t miss out on these six essential tips from Caroline Guidicelli to build your strategy. If you would like to learn more send me a message. 

It’s here! The new Best Practice Guidance document is now available to download. This new document will guide manufacturers on best practice related to the development of their clinical evaluation documentation under the MDR. Click here to download: https://bit.ly/4791wGH #BSI #Medicaldevices #Clinical #BestPracticeGuidance

BSI's Clinical Evaluation Documentation best practice guidance is out! 💥 The guidance aims to give clear information on the notified body's expectation for clinical evaluation under the MDR. #BSI #medicaldevices #clinicalevaluation

The new Best Practice Guidance document is now available to download!!