Porzio, Bromberg & Newman, P.C.’s Post

Imagine having your biosecurity metrics at your fingertips, updated in real-time. With CertMate, you can track certification status and ensure compliance every step of the way. Stay ahead of the curve and reduce risk. Register for our demo today and experience seamless monitoring. Schedule your complimentary demo now on aevi.tech. #RealTimeData #RiskManagement #DigitalTransformation #Compliance

🔐 𝐄𝐥𝐞𝐯𝐚𝐭𝐢𝐧𝐠 𝐒𝐮𝐜𝐜𝐞𝐬𝐬: 𝐓𝐡𝐞 𝐏𝐨𝐰𝐞𝐫 𝐨𝐟 𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐥 𝐀𝐮𝐝𝐢𝐭 𝐒𝐞𝐫𝐯𝐢𝐜𝐞𝐬 🔐 In the ever-evolving landscape of #MedicalDevices, 𝑰𝒏𝒕𝒆𝒓𝒏𝒂𝒍 𝑨𝒖𝒅𝒊𝒕 𝑺𝒆𝒓𝒗𝒊𝒄𝒆𝒔 are not just a regulatory checkbox—they're the cornerstone of business resilience. 🌟 From ensuring compliance with ISO 13485 to uncovering strategic insights, internal audits drive continuous improvement, prevent fraud, and enhance stakeholder trust. By investing in transparency, you're unlocking your organization's full potential and setting the stage for long-term success. Let us help you transform challenges into opportunities! 🔗 https://lnkd.in/gvN9sY5d #InternalAudit #BusinessResilience #StrategicInsights #ComplianceMatters #QualityFirst #MedicalDeviceRegulation #InternalAudit #BusinessResilience #StrategicInsights #ComplianceMatters #QualityFirst #MedicalDeviceRegulation #ContinuousImprovement #RiskManagement #ISO13485 #FraudPrevention #AuditExcellence

🛑 Are you ready to tackle subjectivity in your #riskmanagement ? Check out our blog to learn more on how to minimize subjectivity! 👇 ValGenesis

Hello LinkedIn Community, Contemplating the words of Warren Buffett, "Risk comes from not knowing what you're doing," DP Distribution & Consulting, LLC® positions itself as your guide to mitigate risks in the realm of compliance and regulatory services for medical device manufacturing. As providers of comprehensive services, we understand the critical importance of having the right knowledge in risk management. Just as Buffett emphasizes, our commitment is to ensure that you are well-informed, and equipped with the understanding needed to navigate the complexities of regulatory compliance in the medical device industry. Ready to eliminate risks through knowledge? Connect with DP Distribution & Consulting, LLC® today at dpdconline.com for compliance and regulatory services that empower you with the expertise needed to mitigate risks effectively. #KnowledgeMitigatesRisk #regulatoryexcellence #DPDConsulting #complianceservices #connectwithus #medicaldevicemanufacturing #consultingexcellence

Make sure you know what you're doing once the QMSR becomes effective...

Dive into the world of risk-based compliance strategies to navigate the evolving landscape of regulated substances! Join us as we explore practical steps and seamless integration into your organization's quality management system. Register: https://lnkd.in/e2pxm6hT #ComplianceStrategies #RiskManagement #QualityManagement #RegulationsUpdate #Intertek #IntertekAssuris

Navigating the OIG's new #Compliance Program Guidance? Join our webinar featuring our Solution expert in Governance, Risk Management, and Compliance, Lynne Rinehimer, Esq. along with Chief Compliance Officer from San Juan Regional Medical Center, Patricia Supanich-Wall, CHC, CPC, CHPC, as they break down the latest updates and share practical insights for implementing change.

🔍 How do regulatory changes impact risk assessment processes in life sciences organizations? 🌟Happy #FixItFriday life sciences pros! Today, let’s tackle Adapting to Regulatory Changes. 📜🔍 Turn regulatory changes into opportunities! Unlock the answer here 👉https://lnkd.in/d9bXZ7ms #FixItFriday #LifeSciences #Compliance #Innovation #RegulatoryChange

👀 What is the 'CREEP FACTOR’? 👀 💡 It's a term that we use to describe risk... ⚠ If effective monitoring is NOT in place, mistakes (human or otherwise) can start to creep in. ⛔ If left undetected and uncorrected, these mistakes can represent a credible compliance risk. 😎 In order to effectively monitor innovative projects, companies need to consider time, resources and costs required at the outset. #abpicode #compliance #risk #pharma #happyfriday

Complying with IVDR requires a strong QMS that not only meets but excels in regulatory standards. This involves a proactive approach to risk management, diligent post-market surveillance, and continual adaptation to regulatory changes. 🧭 Navigating the complexity The transition to #IVDR can seem daunting with its stringent requirements and comprehensive oversight. The stakes are high, as non-compliance can result in significant setbacks, from delays in product launches to potential legal challenges. Ensuring that every aspect of the QMS aligns with IVDR standards is critical, yet complex, requiring a clear understanding and strategic planning to overcome potential hurdles. Here are essential strategies to ensure full IVDR #Compliance: ① Start early: Begin your compliance journey well ahead of deadlines to ensure all processes are thoroughly implemented and validated. ② Engage with notified bodies: Building a strong relationship with notified bodies can provide crucial insights into the certification expectations under IVDR. ③ Invest in training: Provide training to key personnel on IVDR requirements, #QMS principles, risk management techniques, and other relevant topics to ensure a thorough understanding of compliance obligations. ④ Stay informed: Keep up with the latest regulatory updates and industry best practices to maintain and refine your compliance strategies. ⑤ Leverage technology: Explore software solutions and digital tools to streamline QMS processes, facilitate #DocumentManagement, and enhance traceability and transparency. The key to success is to implement a robust electronic Quality Management System (eQMS).  Are you ready to master IVDR compliance? Dive deeper into our comprehensive guide and ensure your QMS is up to par. Visit our blog for more insights and practical tips >> https://bit.ly/3VoO4K3