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Matrix Requirements
United States
Registrace 2. 11. 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.
What Is Requirements Management?
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 Management ensures that these technologies not only meet specific clinical needs but also comply with stringent regulatory standards that govern their safety, reliability, and effectiveness.
Learn more about Requirements Management in Medical Devices here:
matrixreq.com/blog/what-is-requirements-management-in-medical-devices?
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 Management ensures that these technologies not only meet specific clinical needs but also comply with stringent regulatory standards that govern their safety, reliability, and effectiveness.
Learn more about Requirements Management in Medical Devices here:
matrixreq.com/blog/what-is-requirements-management-in-medical-devices?
zhlédnutí: 42
Video
CE Marking Explained: How do you apply for certification?
zhlédnutí 56Před měsícem
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!
zhlédnutí 3,2KPřed měsícem
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.
zhlédnutí 148Před 2 měsíci
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)?
zhlédnutí 10KPřed 2 měsíci
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.
zhlédnutí 621Před 2 měsíci
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!
zhlédnutí 77Před 3 měsíci
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
zhlédnutí 181Před 3 měsíci
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...
FDA Software Validation Documentation: All you need to know
zhlédnutí 133Před 4 měsíci
Software Validation Documentation for FDA 510(k) premarket notification submission The Software validation documentation for the FDA (U.S. Food and Drug Administration) is an essential part of the regulatory submission for medical devices that contain software or are software themselves. The FDA requires that medical device manufacturers demonstrate through documentation that all software used ...
CAPAS: Zoom in on Root Cause Analysis and CAPA Effectiveness check
zhlédnutí 44Před 4 měsíci
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?
zhlédnutí 44Před 4 měsíci
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
zhlédnutí 101Před 4 měsíci
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
zhlédnutí 1,4KPřed 5 měsíci
This webinar aims to guide medical device manufacturers through the intricate process of launching products in the European Union and the United States. Attendees will gain insights into the regulatory landscapes of both regions, understand the critical differences, and learn strategic approaches for successful market entry. Topics covered will include regulatory compliance, market access strat...
AI Act in Medical Device Industry & Europe - Key Objectives & What you need to know.
zhlédnutí 290Před 5 měsíci
The digital age has ushered in an era where artificial intelligence (AI) is no longer a figment of science fiction but a reality that shapes our daily lives, especially within the European Union (EU). With the introduction of the world's first comprehensive AI regulation, the EU AI Act, the bloc is setting a global benchmark in how AI should be governed. This regulation not only aims to foster ...
How to Prepare a Medical Device 510k Submission for FDA
zhlédnutí 1,2KPřed 5 měsíci
There are several entry points for launching a medical device to market in the US. There are 3 main entry points, the first being de novo entry - Which is an entry without a predicate device. Then there is the PMA, which is the Pre Market Authorisation entry model, which is mainly for high risk (Class 3) devices, and finally there is the 510(k) process which is the most commonly used. This vide...
Bridging the Gap between Agile Methodologies & Compliance
zhlédnutí 53Před 5 měsíci
Bridging the Gap between Agile Methodologies & Compliance
What is 21 CFR Part 820? How does this impact your Medical Device in US.
zhlédnutí 1,5KPřed 6 měsíci
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
zhlédnutí 43Před 6 měsíci
Navigating Regulatory Affairs and Ensuring Compliance in a Medtech Startup
How will the AI Act in Europe impact Medical Devices?
zhlédnutí 276Před 6 měsíci
How will the AI Act in Europe impact Medical Devices?
Sivan Innovation & Matrix Requirements
zhlédnutí 56Před 7 měsíci
Sivan Innovation & Matrix Requirements
Pytheas Navigation & Matrix Requirements
zhlédnutí 92Před 9 měsíci
Pytheas Navigation & Matrix Requirements
SxMD Templates with Matrix Requirements
zhlédnutí 179Před 9 měsíci
SxMD Templates with Matrix Requirements
Matrix Requirements Compose feature release
zhlédnutí 238Před rokem
Matrix Requirements Compose feature release
Matrix Requirements. Requirements Management & Quality Management for Medical Devices.
zhlédnutí 557Před rokem
Matrix Requirements. Requirements Management & Quality Management for Medical Devices.
Matrix Requirements: 2022 Annual Offsite - Las Palmas, Spain
zhlédnutí 167Před rokem
Matrix Requirements: 2022 Annual Offsite - Las Palmas, Spain
Matrix Requirements Webinar: What's new in version 2.3?
zhlédnutí 435Před 2 lety
Matrix Requirements Webinar: What's new in version 2.3?
Is 510k documents needed for ultrasonic dental tartar removal machine?
💕 promo sm
Looks relaxing!
Very clear explanation 😊
Congrats Great team ❤
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