💻 Case Study: The FDA’s Digital Health Future – Regulating Software as a Medical Device (SaMD) As digital health technology advances, the FDA’s approach to regulating Software as a Medical Device continues to evolve. In this case study, EMMA International partnered with a digital health innovator to: ✔️ Determine SaMD classification and submission strategy ✔️ Implement a compliant QMS aligned with ISO 13485 & IEC 62304 ✔️ Establish validation and documentation frameworks ✔️ Achieve FDA clearance with reduced review time #DigitalHealth #SaMD #AIinHealthcare #Compliance #LifeSciences #EMMAInternational

💻 Understanding Equivalence with Software under MDR Equivalence is especially tricky for medical software — do you really have the same algorithm? 🤔 Under EU MDR, proving equivalence means verifying data quality, analysis methods, and ongoing performance through PMCF. 💡 Certification isn’t the finish line — you must keep collecting and updating clinical evidence to stay compliant. Monir El Azzouzi For full episode, Check: https://lnkd.in/eWAC8T6Y #EUMDR #SoftwareAsAMedicalDevice #ClinicalEvidence #MedTech #RegulatoryAffairs #Compliance #PMCF #QualityAssurance

📝Your report's goal is to be a engineer’s to-do list, not an archive. ❤️ Focus the Human Factors Formative Report on Actionable Design Iteration. Clearly separate: Observations (what happened) Findings (why it matters) Recommendations (what to change) Use a prioritized, numbered list of recommendations, linking each directly to the specific design feature or risk it addresses. #MedicalDevices #FDAApproval #HumanFactorsEngineering #UsabilityEngineering #MedTechStartups #Regulatory #ClassII #ClassIII #QualitySystems #DesignControls #FDA510k #PMA #RiskManagement #MedTechInnovation #Healthcare

Compliance doesn't have to slow you down. But it will if you treat it as something you add on at the end. Life sciences companies that move fastest build compliance into their foundation. Their EDC configurations are submission-ready from the first patient. Their standard operating procedures are written before they need them, not during an audit. Their quality checks happen in real-time, not in frantic weeks before a database lock. #expertisedelivered  #lifesciences  #slipstream  

Check out these 4 ways to survive FDA review and secure first-cycle approval. ✔️ Preempt reviewer skepticism ✔️ Bulletproof simulation data ✔️ Eliminate misalignment ✔️ Build a reviewer-proof submission Apply these quick wins now to strengthen your submission and avoid preventable setbacks. Find more resources: https://hubs.la/Q03LkTkn0 #ModalitySolutions #FDACompliance #ColdChainSolutions #PharmaLogistics #RegulatoryReadiness

A well-structured technical file can save months of back-and-forth, audit queries, and stress. It is where technical expertise meets regulatory precision and when done right, it reflects how deeply you understand your own design. When documentation is clear, connected, and complete, audits become conversations, not confrontations. After all, building compliant, coherent files isn’t about ticking boxes, it is about building trust. That’s the mindset we bring at VIDHA QRA Solutions - helping teams turn documentation into a true competitive advantage. 🔗 Know more: https://vidhaqra.com #MedicalDevices #RegulatoryAffairs #QualityManagement #TechnicalFile #ISO13485 #EUMDR #MDR #CDSCO #ICMED #MedTech #Compliance #VidhaQRA #VidhaQRASolutions #DocumentationDoneRight #QMS #MedTech #QualityCulture #ContinuousImprovement #ComplianceSimplified #MedTechIndia

🧩 The Overlooked Power of a Good Technical File Many medical device companies see the Technical File as paperwork to complete before submission. But in reality, it’s your product’s compliance passport — a living document that tells your device’s story from design to market. A well-structured Technical File: ✅ Simplifies audits and reviews ✅ Reduces delays during Regulatory submissions ✅ Reflects a manufacturer’s control over design, risk, and quality ✅ Supports post-market vigilance with traceable records When done right, it’s not just about regulatory checkboxes — it’s about confidence. Confidence that your device stands up to global scrutiny. At Vidha QRA Solutions, we help manufacturers structure their files strategically — not just compliantly — so they work for your organization, not against your timelines. 💡 Because good documentation doesn’t slow you down — it propels you forward. 🔗 Know more: https://vidhaqra.com #MedicalDevices #RegulatoryAffairs #QualityManagement #TechnicalFile #ISO13485 #EUMDR #MDR #CDSCO #ICMED #MedTech #Compliance #VidhaQRA #VidhaQRASolutions #DocumentationDoneRight #QMS #QualityCulture #ContinuousImprovement #ComplianceSimplified #MedTechIndia

True compliance isn’t a checkbox exercise. It takes structure, discipline, clear documentation, and a mindset that safety comes first. In this article, learn what #compliance really entails and how CriTech Research, Inc. ensures your medical device software not only meets, but exceeds regulatory standards. 📃: https://hubs.ly/Q03MKgwt0 – #MedDeviceUS25 #GenerisAMD #MedTech #MedTechInnovation

𝗞𝗻𝗼𝘄 𝗬𝗼𝘂𝗿 𝗕𝗶𝗴𝗴𝗲𝘀𝘁 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝗥𝗶𝘀𝗸: 𝟮𝟭 𝗖𝗙𝗥 𝟴𝟮𝟬.𝟭𝟬𝟬(𝗮) For the past 17+ years, the #1 FDA inspection citation for medical device companies has been the same: 𝗜𝗻𝗮𝗱𝗲𝗾𝘂𝗮𝘁𝗲 𝗖𝗼𝗿𝗿𝗲𝗰𝘁𝗶𝘃𝗲 𝗮𝗻𝗱 𝗣𝗿𝗲𝘃𝗲𝗻𝘁𝗶𝘃𝗲 𝗔𝗰𝘁𝗶𝗼𝗻 (𝗖𝗔𝗣𝗔) 𝗽𝗿𝗼𝗰𝗲𝗱𝘂𝗿𝗲𝘀. FDA’s citations for CAPA systems are due to 4 main gaps: ❌ Lack of documented, implemented, and effective procedures. ❌ Inaccurate or insufficient problem statement and scope ❌ Poor and inadequate investigation and root cause analysis. ❌ Failure to verify that corrective actions were effective. These weaknesses in CAPA systems are more than audit findings – they’re 𝗹𝗲𝗮𝗱𝗶𝗻𝗴 𝗶𝗻𝗱𝗶𝗰𝗮𝘁𝗼𝗿𝘀 𝗼𝗳 𝘀𝘆𝘀𝘁𝗲𝗺𝗶𝗰 𝗤𝗠𝗦 𝗴𝗮𝗽𝘀. Left unaddressed, they can escalate into 𝗰𝗼𝘀𝘁𝗹𝘆 𝗿𝗲𝗺𝗲𝗱𝗶𝗮𝘁𝗶𝗼𝗻, 𝘄𝗮𝗿𝗻𝗶𝗻𝗴 𝗹𝗲𝘁𝘁𝗲𝗿𝘀, 𝗰𝗼𝗻𝘀𝗲𝗻𝘁 𝗱𝗲𝗰𝗿𝗲𝗲𝘀, 𝗮𝗻𝗱 𝗱𝗲𝗹𝗮𝘆𝗲𝗱 𝗺𝗮𝗿𝗸𝗲𝘁 𝗮𝗰𝗰𝗲𝘀𝘀.  At 𝗟𝟲𝗘𝗣 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗼𝗻𝘀𝘂𝗹𝘁𝗶𝗻𝗴, we help medical device companies build robust, compliant, and scalable CAPA programs that are: ✅ Fully aligned with 𝟮𝟭 𝗖𝗙𝗥 𝟴𝟮𝟬.𝟭𝟬𝟬 and 𝗙𝗗𝗔 𝗤𝗠𝗦𝗥 (effective February 2026) ✅ Integrated with 𝗜𝗦𝗢 𝟭𝟯𝟰𝟴𝟱:𝟮𝟬𝟭𝟲 – 𝗖𝗹𝗮𝘂𝘀𝗲 𝟴.𝟱 and 𝗜𝗦𝗢 𝟭𝟰𝟵𝟳𝟭 risk-based requirements ✅ Built on industry best practices for 𝗿𝗼𝗼𝘁 𝗰𝗮𝘂𝘀𝗲 𝗮𝗻𝗮𝗹𝘆𝘀𝗶𝘀, 𝘁𝗿𝗲𝗻𝗱𝗶𝗻𝗴, 𝗮𝗻𝗱 𝗲𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲𝗻𝗲𝘀𝘀 𝗰𝗵𝗲𝗰𝗸𝘀. Our team specializes in transforming CAPA from a “reactive fix” to a 𝗽𝗿𝗼𝗮𝗰𝘁𝗶𝘃𝗲 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗲𝗻𝗴𝗶𝗻𝗲 that drives continuous improvement and protects patient safety. A strong CAPA system isn’t just about avoiding FDA 483s — it’s about building a culture of quality, accountability, and profitability through operational excellence. 📩 Connect with our team at 𝗟𝟲𝗘𝗣 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗼𝗻𝘀𝘂𝗹𝘁𝗶𝗻𝗴 to schedule a consultation to discuss your CAPA system. #FDAinspections #MedTech #QualityAssurance #ComplianceRisk #CAPAdeficiencies  https://lnkd.in/gQKPr2XY

The consistency of these statistics year after year should be a clarion call to US device companies to focus on these components of their quality systems and ensure they receive attention at periodic management reviews.