Explore a wealth of articles, insights, and updates on engineering & compliance in the Matrix One blog. Discover expert tips, industry trends, and valuable information to optimize your project development processes, compliance and quality management.

Master requirements management and traceability matrices (RTM) for IEC 62304 software and ISO 13485 medical device compliance.

 Requirements Management & Traceability Matrix for Medical Devices

Understand Design History Files (DHF) and Design and Development Files (DDF) requirements under FDA 21 CFR 820 & ISO 13485.

DHF & DDF Explained: Design History File and Design and Development File

Build a scalable, HIPAA-compliant remote patient monitoring platform in weeks. Matrix Connect provides the pre-certified cloud infrastructure medical device manufacturers need.

Remote Patient Monitoring Platform for Medical Device Manufacturers | Matrix Connect

Remote Patient Monitoring Platform: Build Faster with Pre-Built Cloud Infrastructure

A practical guide to IEC 62304 compliance for medical device software, including lifecycle requirements, safety class classification, and how Matrix Connect supports your regulatory submissions.

IEC 62304 Compliance for Medical Device Software | Matrix Connect

IEC 62304 Compliance for Medical Device Software: A Practical Guide

A step-by-step guide to connecting a medical device to the cloud — covering connectivity protocols, data architecture, security, compliance, and the fastest path to production.

How to Connect a Medical Device to the Cloud: Step-by-Step Guide | Matrix Connect

How to Connect a Medical Device to the Cloud: A Step-by-Step Guide

What HIPAA requires for medical device cloud platforms, how to achieve and maintain compliance, and how Matrix Connect simplifies HIPAA for device manufacturers.

HIPAA-Compliant Medical Device Cloud: Requirements & Solutions | Matrix Connect

HIPAA-Compliant Medical Device Cloud: Requirements and Solutions

How remote monitoring devices are transforming healthcare delivery, what manufacturers need to know about connectivity and compliance, and how Matrix Connect accelerates time to market.

Remote Monitoring Devices in Healthcare: Guide for Device Manufacturers | Matrix Connect

Remote Monitoring Devices in Healthcare: The Manufacturer's Guide

Should you build custom medical device cloud infrastructure or buy a proven platform? Compare real costs, timelines, compliance burden, and long-term maintenance trade-offs.

Build vs. Buy Medical Device Cloud Connectivity: Cost Analysis | Matrix Connect

Build vs. Buy: Medical Device Cloud Connectivity

How cloud-based medical devices work, why manufacturers are adopting cloud connectivity, and what compliance requirements apply. Practical guidance from Matrix Connect.

Cloud-Based Medical Devices: Architecture, Benefits & Compliance | Matrix Connect

Cloud-Based Medical Devices: Architecture, Benefits, and Compliance

Everything medical device manufacturers need to know about building connected medical devices — data architecture, cloud connectivity, compliance requirements, and best practices.

Connected Medical Devices: Complete Guide for Manufacturers | Matrix Connect

Connected Medical Devices: The Complete Manufacturer's Guide

Understand medical device cybersecurity requirements, risk management, and best practices. Learn how Matrix Connect helps manufacturers meet FDA, HIPAA, ISO 27001, and NIST standards.

Medical Device Cybersecurity: Complete Guide for Manufacturers | Matrix Connect

Medical Device Cybersecurity Guide 

Compare FMEA, FTA, HAZOP, PHA, and Bowtie risk analysis methods for medical device compliance under ISO 14971 standards.

5 Risk Analysis Methods Under ISO 14971: HAZOP, FMEA, FTA, PHA and Bowtie

Master design change control procedures for medical devices. Ensure FDA 21 CFR 820 & ISO 13485 compliance with proven process steps.

Design Change Control: Document Control & Traceability Best Practices

Demystify medical device documentation. Understand DHF, DMR, DHR, DDF, MDF differences and compliance requirements across FDA, ISO, and EU MDR.

DHF vs DMR vs DHR vs DDF vs MDF: Medical Device Documentation Acronyms Explained

Navigate medical device software compliance. Master IEC 62304, ISO 14971, and ISO 13485 integration for SaMD and embedded software validation.

Medical Device Software Compliance: IEC 62304, ISO 14971 & ISO 13485 Together

Master end-to-end medical device traceability. Learn how to link user needs, requirements, risk controls, verification, and regulatory submission in one traceable chain.

Medical Device Traceability: From User Needs to CE Marking

Learn when and how to apply design freeze in medical device development, the design freeze checklist, and managing changes after freeze.

Design Freeze in Medical Device Development: How and When to Apply It

Learn design control requirements under FDA 21 CFR 820.30 and ISO 13485: the 8-step process, documentation needs, and common inspection failures.

Medical Device Design Control: A Complete Guide to ISO 13485 & FDA Requirements

Master ISO 14971 risk management: learn the 7-step process, risk acceptability criteria, and how to create a compliant risk management file.

ISO 14971 Risk Management for Medical Devices: A Complete Process Guide

Learn what a Device Master Record contains, DMR vs DHF differences, and how to maintain compliance with FDA 21 CFR 820 and ISO 13485.

Device Master Record (DMR): What It Contains and Why It Matters

Learn the difference between design verification and validation for medical devices, and how MatrixReq ensures full traceability and design control.

Design Verification and Validation in Medical Devices

How to master verification & validation ?

Simplify (EU) 2025/1234 compliance: Discover how the expanded eIFU scope removes category limits and streamlines digital distribution for professional devices.

Implementing electronic Instructions For Use (eIFU) under (EU) 2025/1234

Electronic Instructions For Use (eIFU) under (EU) 2025/1234

Read more about the acquisition of dokspot Gmbh by Matrix One and the launch of Matrix eIFU.

Matrix One acquires dokspot GmbH to launch Matrix eIFU

Matrix One acquires dokspot GmbH

Register your eIFU URL in EUDAMED before 28 May 2026. Step-by-step guide to Part B point 22, persistent URL requirements, Switzerland deadline, and enforcement.

EUDAMED and eIFU - How to register your URL

EUDAMED eIFU URL Registration: May 2026 Deadline Guide

EUDAMED and eIFU: How to Register Your URL Before the May 2026 Mandatory Deadline

Learn how to achieve IEC 62304 compliance without rigid templates. Discover how connected lifecycle management and MatrixReq simplify medical device software documentation and traceability.

IEC 62304 compliance: how to connect the dots in medical device software

IEC 62304 compliance without the chaos

Learn how to define user needs, write clear requirements, and maintain traceability to strengthen your medical device design control process.

How to Write User Needs & Requirements for Medical Device Design Control

How to write effective user needs and requirements for medical device design control

Learn how traceability enhances ISO 14971 and IEC 62304 risk management. See how MatrixReq connects risks, requirements, and tests for full compliance.

ISO 14971 risk management and traceability for MedTech teams

Strengthen ISO 14971 risk management with traceability

EU Regulations 2021/2226 and 2025/1234: what changed for eIFU eligibility, persistent URL, EUDAMED registration, and 7-day paper request under MDR.

EU Regulation 2021/2226 and 2025/1234: eIFU Rules Explained

EU Regulation 2021/2226 and 2025/1234: What Changed and What It Means for Your Device

In 2024, the cybersecurity landscape for advanced medical devices is more important than ever. With devices increasingly connected through the Internet of Things (IoT) and integrated into healthcare networks, the potential risks to patient safety and data security are increasing.

Updating Cybersecurity for Advanced Medical Devices: 2024 Insights and Best Practices

Cloud computing is a critical baseline for digital transformation across numerous industries, and healthcare technology is no exception. The need for secure, scalable, and compliant data management solutions is more pressing than ever.

The Impact of Cloud Computing in the Medical Device Industry

Discover how to streamline your Medical Device software development with the right tools, from paper-based systems to industry-specific ALM solutions.

Get your Medical Device software to market on any budget

Get your Medical Device software in market on any budget

Modern medicine increasingly relies on cloud computing services to manage, store, and analyze critical digital health data. Connected medical devices and Software as a Medical Device (SaMD) are a fast-growing segment of the healthcare industry’s cloud computing landscape.

Top 5 Must-Have Features in a Medical Device Cloud Platform

Discover the FDA medical device registration process with our comprehensive guide. Learn the essential steps for registering your medical device, including documentation requirements, submission procedures, and tips for a smooth approval process. Ensure your device meets FDA standards and enters the market efficiently.

FDA Medical Device Registration Process: A Step-by-Step Guide for Manufacturers

Discover essential guidelines for HIPAA (Health Insurance Portability and Accountability Act) compliance and learn how to protect patient privacy effectively. Our blog covers key strategies for healthcare providers to ensure secure management of health information and meet regulatory requirements. Stay informed on best practices for safeguarding patient data and navigating HIPAA regulations.

Navigating HIPAA (Health Insurance Portability and Accountability Act): Essential Guidelines for Protecting Patient Privacy

Navigating HIPAA: Essential Guidelines for Protecting Patient Privacy

Master the General Safety and Performance Requirements (GSPR) under the EU MDR and IVDR with our in-depth guide. Explore essential compliance standards, regulatory updates, and practical steps to ensure your medical devices and in-vitro diagnostics meet EU safety and performance criteria effectively.

The ultimate guide to the EU MDR and IVDR general safety and performance requirements (GSPR)

Essential Performance Requirements (EPRs): Key Compliance Guidelines for Medical Devices Learn what Essential Performance Requirements (EPRs) are and how they impact the design and approval of medical devices. Our guide breaks down EPRs, offering crucial insights into compliance standards and ensuring your devices meet essential safety and performance criteria.

Understanding Essential Performance Requirements (EPRs): Key Compliance Guidelines for Medical Devices

Navigate Australia’s medical device regulations with ease. Discover key compliance requirements, approval processes, and essential tips for manufacturers to ensure your devices meet local standards and enter the market smoothly. Stay informed and stay ahead with our comprehensive guide.

Australia Medical Device Regulations: What Medical Device Manufacturers Need to Know

Australia Medical Device Regulations

Discover how big data is revolutionizing medical device software. Explore the benefits, including enhanced patient outcomes, improved product development, and operational efficiency. Learn about the challenges, particularly in regulatory compliance, and get insights into future trends like AI, IoT, and blockchain. Embrace the power of big data to stay ahead in medtech and drive innovative healthcare solutions.

Leveraging Big Data in Medical Device Software

Discover the Role of Blockchain in Medical Device Software and potential applications and benefits of blockchain technology in securing medical device software data.

The Role of Blockchain in Medical Device Software: Potential applications and benefits

Discover the key benefits and challenges of integrating medical device software with EHR systems. Learn essential steps to ensure seamless data flow and maintain compliance in your integration process.

Integrating Medical Device Software with EHR Systems: Benefits and challenges of integration

Unlock the essentials of Canadian medical device regulations with our comprehensive guide. From approval processes to compliance tips, get everything you need to navigate Canada's regulatory landscape effectively. Stay informed and ensure your medical device meets all the necessary standards with ease.

Canadian Medical Device Regulations: Everything to know

Stay compliant with FDA cybersecurity regulations. Discover what the FDA expects for medical device cybersecurity, including risk management, post-market surveillance, and the latest guidelines. Ensure your medical technology meets regulatory standards and protects patient data effectively.

Cybersecurity: What’s expected by the FDA?

Cybersecurity: What’s expected by the FDA

Discover the essential best practices and cutting-edge innovations in medical device packaging. From regulatory compliance to sustainable solutions, this ultimate guide covers everything you need to ensure your products are safely and effectively packaged. Stay ahead in the medtech industry with the latest trends and expert insights.

Ultimate Guide to Medical Device Packaging: Best Practices & Innovations

Discover how SOP documentation can transform your business operations from chaos to clarity. Learn the importance of Standard Operating Procedures and how they boost efficiency, consistency, and scalability in tech startups. Unlock the secrets to seamless growth and operational excellence.

From Chaos to Clarity: The Power of SOP Documentation

Discover what ISO standards are, why they are essential, and how they can benefit your tech startup. Get insights on compliance, quality assurance, and global market reach.

ISO Standards Explained: Why They Matter for Your Business

Explore the future of digital healthcare in medical devices and discover how innovative solutions are transforming the industry. This comprehensive guide for medical device manufacturers highlights the latest advancements and trends in digital healthcare, offering insights into how these technologies can revolutionize patient care and improve operational efficiency. Don't miss out on the essential information that could shape the future of your business. Learn more today!

The Future of Digital Healthcare in Medical Devices

Discover the top medical device tradeshows to attend in 2024. Explore key events, networking opportunities, and industry trends that can propel your medical technology business forward.

Top Medical Device Tradeshows: Must-Attend Events for 2024

Discover everything you need to know about Change Impact Analysis in our essential guide. Learn how to assess, manage, and mitigate risks associated with changes in your projects. Perfect for project managers, business analysts, and change management professionals looking to streamline processes and ensure successful outcomes.

Change Impact Analysis: The Essential Guide

Explore essential guidelines for postmarket surveillance under 21 CFR Part 822. Learn how compliance ensures ongoing safety monitoring and regulatory adherence for medical devices, enhancing consumer trust and product reliability.

Critical Insights into Postmarket Surveillance: Compliance with 21 CFR Part 822

Discover what a test case is and learn expert tips for writing effective test cases in software testing. Improve your testing strategy with our top recommendations and ensure robust software quality assurance. Dive into essential techniques for creating precise test cases that enhance your development process.

What is a test case? Top tips to Write Test Cases in Software Testing.

What is test case. Top tips to Write Test Cases in Software Testing.

Discover the crucial differences between Functional vs Non-Functional Requirements. Uncover why both are essential for your tech project's success. Get expert insights now!

Functional vs Non-Functional Requirements. Everything you need to know.

Discover how AAMI standards ensure robust cybersecurity for medical devices. Learn why compliance is crucial for patient safety and regulatory approval. 

AAMI Standards and Cybersecurity in Medical Devices

Discover everything you need to know about LLM (Large Language Models) in Medical Devices. Learn how AI-powered language models are revolutionizing the medical technology sector, enhancing diagnostics, patient care, and regulatory compliance. Explore the impact of LLMs on innovation and efficiency in medical devices today!

LLM in Medical Devices, everything you need to know.

Learn about the Safe Medical Devices Act and its impact on the medical technology industry. Discover key requirements, compliance strategies, and how this crucial legislation helps ensure the safety and effectiveness of medical devices.

Safe Medical Devices Act Definition: Ensuring Safety and Compliance in Medical Technology

Discover the ultimate guide to the software development lifecycle (SDLC), featuring best practices and insights for tech innovators. Learn how to streamline development processes, ensure quality, and achieve successful product launches in the dynamic tech industry.

What is the SDLC? Software Development Lifecycle: Best Practices for Tech Innovators

Ultimate Guide to the Software Development Lifecycle: Best Practices for Tech Innovators

Discover essential insights into labeling requirements for medical devices under 21 CFR Part 801. Learn about compliance guidelines, best practices, and regulatory nuances to ensure accurate and effective labeling that meets FDA standards.

Decoding Labeling Requirements: Understanding 21 CFR Part 801 for Medical Devices

Explore our comprehensive guide to Medical Device Reporting (MDR) under 21 CFR Part 803. Gain insights into regulatory requirements, reporting obligations, and best practices to ensure compliance and enhance safety in the medical device industry.

Medical Device Reporting (MDR): Compliance Guide to 21 CFR Part 803

A Class II (Class 2) medical device in the US is a moderate to high-risk device requiring FDA's 510(k) clearance for market entry. These devices must meet specific regulatory controls to ensure safety and effectiveness. Examples include powered wheelchairs and infusion pumps. Learn about the classification and compliance standards for Class 2 medical devices in the US.

What is a Class II (Class 2) Medical Device in the US?

What is a Class II (Class 2) Medical Device in the US

Explore this essential template for AI risk management within the Matrix Requirements QMS or ALM. Ensure effective management of AI-related risks with a customizable template designed to enhance compliance, security, and performance.

Essential template for AI risk management in your QMS or ALM

Essential Templates for AI Risk Management within your QMS

Explore the essential aspects of the ISO 11607 series, crucial packaging standards for medical devices. Learn how compliance with ISO 11607 ensures product safety, sterility, and regulatory adherence in the medical technology industry.

Mastering ISO 11607: Packaging Standards for Medical Devices

3 FDA Medical Device Classes Explained SimplyMastering ISO 11607: Packaging Standards for Medical Devices

Discover the differences between the 3 FDA medical device classes with clear explanations and examples. Learn about Class I, II, and III devices and their regulatory paths to market.

3 FDA Medical Device Classes Explained Simply

Explore MedWatch: FDA's vital program for safety information and reporting adverse events. Learn how it safeguards public health and ensures medical product safety.

Understanding MedWatch: FDA's Essential Program for Safety Information and Adverse Event Reporting Form

Understanding MedWatch: FDA's Essential Program for Safety Information and Adverse Event Reporting

Learn how to demonstrate substantial equivalence for medical devices with our easy 3-step guide. Navigate the FDA 510(k) process efficiently to bring your device to market faster.

How to Demonstrate Substantial Equivalence of Medical Devices in 3 Steps

Explore the comprehensive journey of a medical device from concept to market. Learn about the key stages, regulatory requirements, and best practices to ensure successful development, compliance, and commercialization in the medical technology industry.

Navigating the Medical Device Lifecycle: From Concept to Market

Discover the essentials of EU MDR with answers to the top 10 critical questions. Learn about regulatory changes, compliance requirements, and how EU MDR impacts medical device manufacturers navigating the European market.

What is EU MDR? Top 10 Critical Questions Answered.

What is EU MDR. Top 10 Questions Answered.

Discover how IEC 60601 ensures safety and compliance in medical devices. Explore key standards and their impact on product reliability and regulatory adherence.

How IEC 60601 helps ensure Safety and Compliance in Medical Devices

Discover the essentials of eQMS software—your ultimate guide to understanding Electronic Quality Management Systems. Learn how eQMS can streamline compliance, enhance efficiency, and ensure top-notch quality management in your organization. Get insights on key features, benefits, and implementation strategies to stay ahead in the competitive landscape.

eQMS Software (Electronic Quality Management System): Everything you need to know

Explore the significance of In Vitro Diagnostics (IVDs) in modern healthcare. Learn about IVD categories, regulatory frameworks, technological advancements, and their pivotal role in personalized medicine. Gain essential insights to innovate and navigate the evolving landscape of diagnostic technologies.

Understanding In Vitro Diagnostics (IVDs): Essential Insights for Healthcare Innovators

A Class 3 medical device in the US is classified by the FDA as posing the highest risk to patients and users. These devices, which include items like pacemakers and heart valves, require extensive testing, clinical trials, and premarket approval (PMA) to ensure safety and efficacy. Understanding Class 3 medical device regulations is crucial for developers to navigate compliance and ensure their products meet stringent FDA standards.

What is a Class 3 Medical Device in the US?

A Comprehensive Guide to Class 3 Medical Devices in the US

Medwatch Form is a critical tool for reporting adverse events and product problems in the medical field. Discover its purpose, how to fill it out, and why it's essential for patient safety and compliance. Get all the insights you need here.

What is a Medwatch Form? All you need to know.

What is a Medwatch Form. All you need to know.

Discover essential tips for navigating IVDR classification requirements for in vitro medical devices. Learn how to classify devices effectively under the new EU regulations to ensure compliance and streamline the path to market.

Top Tips for IVDR Classification for In Vitro Medical Devices

IVDR Classification for In Vitro Medical Devices Explained

Discover how ISO 10993 standards ensure biocompatibility in medical devices. Learn about tests, compliance requirements, and safety protocols. Enhance your understanding for regulatory compliance and safe product development.

Understanding ISO 10993: Ensuring Safety in Medical Device Biocompatibility

Understand the Intended Use & Purpose under MDR for medical devices. This critical classification defines how a device should be used, its target users, and its clinical benefits, ensuring compliance with EU regulations and enhancing patient safety.

Intended Use & Purpose under MDR for Medical Devices

Intended Use & Purpose under MDR in Medical Device

Discover the essentials of a Laboratory Developed Test (LDT) - custom diagnostic tests created and validated within a single lab to meet unique clinical needs. Learn how LDTs provide innovative, personalized medical testing solutions beyond commercial options.

What is a Laboratory Developed Test (LDT)?

What is Laboratory Developed Test (LDT).

Explore the transformative role of minimally invasive devices in modern medicine. Learn how these cutting-edge medical devices are revolutionizing patient care, improving outcomes, and enhancing the overall healthcare experience.

Minimally Invasive Devices in Modern Medicine & Medical Devices

Unlock the potential of your startup with the PDCA (Plan Do Check Act) cycle. Learn how this powerful framework can help you continuously improve, make data-driven decisions, and achieve sustainable growth. Discover your blueprint for success today!

What is the PDCA (Plan Do Check Act) process? Your Blueprint for Success.

What is the Plan Do Check Act Process

Discover new tools for efficiency, security, and collaboration in our latest SxMD release. Stay ahead with innovative solutions tailored for your needs.

Elevate Your SxMD with Our Latest Features and Enhancements

2.4.2 unveils new tools for efficiency and security

Preparing for EUDAMED is crucial for medical device companies aiming to enter or stay in the European market. This comprehensive guide explores EUDAMED's requirements, benefits, and compliance strategies to help you navigate Europe's essential medical device database effectively.

Getting Ready for EUDAMED: Europe's Essential Medical Device Database

Discover how remote patient monitoring (RPM) is revolutionizing healthcare by leveraging cutting-edge technology to enhance patient care, improve outcomes, and reduce costs. Learn about the latest innovations in RPM, their benefits, and how they're transforming the future of healthcare delivery.

Remote Patient Monitoring & How Technology is Changing Healthcare

Unlock the potential of remanufacturing and servicing in medical devices. Learn how these practices enhance device sustainability, reliability, and cost-effectiveness while ensuring optimal patient care and regulatory compliance.

The Role of Remanufacturing and Servicing in Medical Devices

Discover the key differences between Proof of Principle (PoP) and Proof of Concept (PoC) in the medical device industry. Learn how traceability ensures compliance, quality, and successful development from initial feasibility to a market-ready product.

Proof of Principle vs. Proof of Concept in Medical Devices: Key Differences and Importance of Traceability

Discover how portable medical devices and connected health technologies are revolutionizing healthcare delivery. Explore the benefits of remote monitoring, real-time data analysis, and personalized care in improving patient outcomes and enhancing the overall healthcare experience.

Medical Device Regulatory & Engineering Blog