Intellect ’s Post

Quality Assurance Framework Framework: This is an evidence based decision-making methods used to monitor quality and continuous improvements. Framework is a series of steps you need to take to achieve a particular thing. Quality Assurance Framework are: 1) Planning 2) Testing 3) Risk management #Qavdev20dayschallenge #TechandMe #softwaretesting #QAtester #qaengineer

🎥 Webinar Recap: Navigating the Landscape of SaMD Risk Management 🌐 We're thrilled to share the insightful recording of our recent webinar, where we delved deep into the essential aspects of risk management within the context of Software as a Medical Device (SaMD). 🔍 Key Takeaways: ▶️ Understanding the intricate landscape of SaMD risk management. ▶️ Navigating the nuances of IEC 62304, IEC 82304, and ISO 14971 standards. ▶️ Practical insights to enhance your organization's risk mitigation strategies. 🔗https://hubs.li/Q02cbxGB0 #SaMD #RiskManagement #ALM #Codebeamer #IEC62304 #IEC82304 #ISO14971 #MedicalDevices #HealthTech

SOP stands for “Standard Operating Procedure,” a written guide that tells you how to do specific tasks in a company. Here’s why they’re important: - Consistency - Compliance - Training - Quality Control - Efficiency - Risk Management - Documentation - Continuous Improvement Good SOPs are super important for keeping things running smoothly and ensuring everyone knows what they’re doing. Read the full article on our website: https://lnkd.in/gAvKaE7R #KnowledgeManagement #KPS #SOP

Register for Free here: https://lnkd.in/eBGKGD8q The QA organization of the 21st century is one that improves safety, enterprise performance, and risk management. In this webinar, I will provides insights into a blueprint for enhancing traditional Quality Assurance Programs to deliver higher value in the modern era. Discussions will include the need for change, and five key skills needed to shift oversight mindsets from checklist compliance toward dynamic critical thinking and holistic systems thinking. Also covered are methods for dramatically enhancing our corrective actions to prevent recurrence. #asq #qualityassurance #auditing #problemsolving #criticalthinking #systemsthinking

In this presentation, I will provide insights into a blueprint for enhancing traditional Quality Assurance Programs to deliver higher value in the modern era. Discussions will include the need for change, and tactics for shifting oversight mindsets from checklist compliance toward dynamic critical thinking, systems thinking and corrective action strategies that improve safety, enterprise performance, and risk management.   Don't miss this rare opportunity to level up your QA! Register now for and get a ticket for FREE: https://lnkd.in/diMXAYkX #asq #qualityassurance #auditing #problemsolving #criticalthinking #systemsthinking

Webinar RSVP here: https://lnkd.in/eBGKGD8q The QA organization of the 21st century is one that improves safety, enterprise performance, and risk management. In this webinar, I will provides insights into a blueprint for enhancing traditional Quality Assurance Programs to deliver higher value in the modern era. Discussions will include the need for change, and five key skills needed to shift oversight mindsets from checklist compliance toward dynamic critical thinking and holistic systems thinking. Also covered are methods for dramatically enhancing our corrective actions to prevent recurrence. #asq #qualityassurance #auditing #problemsolving #criticalthinking #systemsthinking

MEDIcept White Paper: Risk Management Series – Part 2: Using Fault Trees to Focus and Simplify Risk Analysis Dive into Part 2 of our Risk Management Series, where we explore the transformative potential of Fault Tree Analysis (FTA) for medical devices. Discover how FTA offers a comprehensive, top-down approach to hazard identification, bridging the gap that traditional FMEA processes often leave. Learn how this method not only simplifies risk analysis but also enhances communication and understanding among your team.  Join authors Brian Siroka, Associate Consultant, and Gregg V., Sr. Software Quality Engineer, as they explore the intricacies of FTA and provide actionable insights to bolster your risk management strategy. Access the White Paper by clicking the link below.  https://lnkd.in/eUxHTYGu Want to elevate your risk management processes? Contact MEDIcept Inc. today at [email protected] to learn how we can help you achieve comprehensive and effective risk analysis.  #MedicalDevices #FTA #FMEA #RiskManagement #RiskAnalysis #Quality #WhitePaper

Have you been in a position where you need to provide acceptance to a specific risk? How can you ensure a proper decision is taken? 🤔 I recently completed my ISO 31000 Risk Assessment Certification and can share my understanding based on it. 🎯 In many instance we witnessed wrong risk acceptance causing great harm to the business. Risk acceptance isn’t an easy call, it requires careful analysis and communication to ensure proper understanding of the risk. To identify and prioritize risk, it needs to be based on their probability and impact, a proper documentation for the rationale and criteria for accepting them, and communicate them to the relevant teams and stakeholders. Risk Acceptance areas should be revisited frequently to ensure that their occurrence and impact didn’t deviate from the time Initial analysis took place, Hence, the documentation is quite essential during this process for future monitoring. #riskmanagement #iso31000 #riskanalysis #riskassessment #riskadvisory #compliancemanagement #itaudit

Risk Management is not something to forget.

Taming the Risk Assessment Beast: How to Get Started with Minimal Resources Developing and implementing a risk assessment program for ISO or regulatory compliance can feel overwhelming. It requires knowledge, resources, and time to gather information, analyze threats, and plan mitigation strategies. But what if I told you could kickstart your risk assessment today with minimal resources and costs? Simpliix MS/GRC can be your secret weapon. This tool streamlines the entire risk assessment cycle, making compliance achievable. Here's how it simplifies the process: --> Guides you through risk identification and analysis. --> Provides templates and forms to save you time. --> Helps you focus on critical risks to prioritize effectively. --> Ensures your reports meet ISO standards and regulatory requirements. Stop letting risk assessment hold you back. Start your journey to compliance today! reach out to [email protected] #grc #governance #risk #compliance #iso