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Matrix Requirements
США
Добавлен 2 ноя 2014
For companies looking to accelerate development of their innovative medical device technologies, the Matrix Requirements platform is an easy-to-use, flexible, all-in-one software solution that: facilitates collaboration of employees on design control, and quality management to streamline medical device design, establish lean quality management, accelerate product certification and go-to-market, and maintain regulatory compliance.
Matrix Requirements is an EN ISO 13485:2016 and ISO/IEC 27001:2013 certified company.
Visit www.matrixreq.com for information.
Matrix Requirements is an EN ISO 13485:2016 and ISO/IEC 27001:2013 certified company.
Visit www.matrixreq.com for information.
Fast Track Your Medical Device Launch in US and EU with Matrix Requirements
This webinar is designed to equip you with insights into the medical device market in the European Union (EU) and the United States (US) as well as understand the tools that are in the market to help you as you scale. Understanding the differences between these two key markets as well as what tools to implement will empower you to develop more effective plans and strategies for a successful medical device launch.
Просмотров: 57
Видео
Developing AI-Powered Medical Devices - Matrix Requirements Webinar
Просмотров 1153 месяца назад
Do you want to implement AI in your medical devices, but unsure about regulations, methodologies and more? Discover the full potential of AI as you develop your medical device. Sign up for our webinar today! In this webinar, you will learn: What are the benefits of using AI in your Medical Device What relationships come first? Customer? Data Scientist or Developer? Discuss the importance of ite...
How To Classify Your Medical Device: Decoding Regulatory Pathways
Просмотров 1414 месяца назад
Join us to understand how different regions categorize medical devices. Ensure compliance and remain empowered with the knowledge to navigate international regulatory landscapes confidently. Whether you’re targeting the US market with its FDA requirements or aiming for EU approval under the rigorous MDR, we’ll break down the complexities and provide clear, actionable insights. By understanding ...
What is MatrixQMS (Quality Management System)?
Просмотров 11 тыс.4 месяца назад
Elevate Your Quality Management with MatrixQMS In this video, we explore the challenges of managing quality in the Software as/in a Medical Device (SxMD) industry-navigating complex regulations, handling CAPAs, training, and maintaining documentation across disconnected systems. What You'll Learn: - How MatrixQMS bridges the gap between design and quality to foster collaboration. - The benefits...
What Is Requirements Management?
Просмотров 1055 месяцев назад
In Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), the practice of managing requirements is crucial. matrixreq.com/blog/the-ultimate-guide-to-software-as-a-medical-device-samd-simd-sxmd-classification As technology continues to integrate deeper into the healthcare landscape, the complexity and regulatory scrutiny of medical software also increase. Requirements Manag...
CE Marking Explained: How do you apply for certification?
Просмотров 6046 месяцев назад
As you start to navigate the CE Certification Mark for Medical Devices in Europe, understanding the regulatory landscape is crucial. If you are a medical device manufacturer aiming to introduce your products into the European market, the European Union requires compliance with the CE certification mark as a gateway to market entry. What is the CE Certification Mark? The CE certification mark, s...
What is ISO 9001? What are the key differences between ISO 9001 and ISO 13485? All you need to know!
Просмотров 3,3 тыс.6 месяцев назад
ISO 9001 vs ISO 13485 What is ISO 9001? ISO standards, alongside those issued by the International Electrotechnical Commission (IEC), are globally recognized benchmarks for harmonized practices. Established in 1947, the International Organization for Standardization (ISO) ensures the safety and quality of products through comprehensive standards covering various aspects such as quality manageme...
IEC 62304: Become an expert in Software Testing. All you need to know.
Просмотров 3346 месяцев назад
Enhance your expertise in software testing with our focused webinar on IEC 62304. Learn key practices and standards crucial for medical device software development. In this webinar, you will learn: Understanding the Importance of Software Testing and why it’s crucial in the development lifecycle Deep dive into IEC 62304 and pivotal points impacting Medical Device Development Common challenges D...
What is MatrixALM (Application Lifecycle Management)?
Просмотров 10 тыс.7 месяцев назад
Streamline your SxMD development with MatrixALM In this video, we address the common challenges faced when developing Software as/in a Medical Device (SxMD), from dealing with outdated paper-based systems to managing complex dependencies and ensuring compliance. What You'll Learn: - How MatrixALM bridges the gap between design, quality, and compliance. - The benefits of a centralized location f...
What is IEC 62304? Everything you need to know to ensure Software Safety.
Просмотров 9127 месяцев назад
Understanding IEC 62304 for Medical Device Software Software safety is paramount. Especially within Medical Devices. The International Electrotechnical Commission (IEC) sets standards to ensure software efficacy. Today, we delve into IEC 62304, its purpose, safety classification, key elements, and compliance. So what is IEC 62304? IEC 62304 serves as a structured framework for managing the life...
Preparing a Device Master Record (DMR): All you need to know!
Просмотров 2177 месяцев назад
One document is very important within in Medical Devices : the Device Master Record (DMR). The Device Master Record (DMR) serves as the comprehensive blueprint or master document for the fabrication of a medical device. It contains all the essential information, specifications, and instructions necessary for the manufacturing process. This includes detailed drawings, design specifications, manu...
High Risk AI under European AI Act: Must know strategies for Medical Device Companies
Просмотров 2278 месяцев назад
In this webinar, you will learn: What qualifies as high-risk AI under the AI Act. The AI Act’s Regulatory Framework with insights into compliance requirements and reporting obligations. Discover effective strategies for conducting risk assessments on AI technologies in medical devices. How to future-proof your Regulatory Approach to stay ahead of the curve. Who should attend: Medical Device com...
CAPAS: Zoom in on Root Cause Analysis and CAPA Effectiveness check
Просмотров 959 месяцев назад
This video aims to zoom in on two specific parts of a Corrective and Preventive Action, also known as (CAPA) - Those two parts being the Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) effectiveness check. Before we dive into it, what is a CAPA? A CAPA, or Corrective And Preventive Action is used to improve processes and products by addressing and eliminating the causes of...
What is ISO 14971 and how will it impact my Medical Device company?
Просмотров 829 месяцев назад
What is ISO 14971? ISO 14971 is an international standard for medical devices, focusing on risk management in Medical Devices. It outlines principles and processes for manufacturers to apply risk management throughout a medical device's lifecycle, aiming to enhance patient safety and product effectiveness. What are the key considerations when thinking about ISO 14971? Medical device manufacture...
Remain Agile within Medical Device Development
Просмотров 1479 месяцев назад
Agile in Medical Devices Development designed for R&D teams like yours in mind. This session dives into the strategic application of Agile methodologies to streamline medical device development, ensuring faster time-to-market and compliance with regulatory standards. Why This Webinar Is Tailored For You? Strategic Insights: Learn how Agile can be strategically implemented in medical device deve...
Launch Medical Device to Market in the EU vs US
Просмотров 1,5 тыс.10 месяцев назад
Launch Medical Device to Market in the EU vs US
AI Act in Medical Device Industry & Europe - Key Objectives & What you need to know.
Просмотров 42910 месяцев назад
AI Act in Medical Device Industry & Europe - Key Objectives & What you need to know.
How to Prepare a Medical Device 510k Submission for FDA
Просмотров 2,5 тыс.10 месяцев назад
How to Prepare a Medical Device 510k Submission for FDA
Bridging the Gap between Agile Methodologies & Compliance
Просмотров 8610 месяцев назад
Bridging the Gap between Agile Methodologies & Compliance
What is 21 CFR Part 820? How does this impact your Medical Device in US.
Просмотров 1,9 тыс.10 месяцев назад
What is 21 CFR Part 820? How does this impact your Medical Device in US.
Navigating Regulatory Affairs and Ensuring Compliance in a Medtech Startup
Просмотров 4910 месяцев назад
Navigating Regulatory Affairs and Ensuring Compliance in a Medtech Startup
How will the AI Act in Europe impact Medical Devices?
Просмотров 37910 месяцев назад
How will the AI Act in Europe impact Medical Devices?
Sivan Innovation & Matrix Requirements
Просмотров 5911 месяцев назад
Sivan Innovation & Matrix Requirements
Pytheas Navigation & Matrix Requirements
Просмотров 109Год назад
Pytheas Navigation & Matrix Requirements
SxMD Templates with Matrix Requirements
Просмотров 197Год назад
SxMD Templates with Matrix Requirements
Matrix Requirements Compose feature release
Просмотров 249Год назад
Matrix Requirements Compose feature release
Matrix Requirements. Requirements Management & Quality Management for Medical Devices.
Просмотров 606Год назад
Matrix Requirements. Requirements Management & Quality Management for Medical Devices.
Is 510k documents needed for ultrasonic dental tartar removal machine?
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Looks relaxing!
Very clear explanation 😊
Congrats Great team ❤
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