Explore a wealth of articles, insights, and updates on effective requirements management in the Matrix Requirements blog. Discover expert tips, industry trends, and valuable information to optimize your project development processes and enhance your understanding of requirement management practices.

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.

Modèles essentiels pour la gestion des risques liés à l'IA au sein de votre QMS ou ALM


Essential template for AI risk management in your QMS or ALM

Essential Templates for AI Risk Management within your QMS

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 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.

Empowering Healthcare: The Impact of Portable Medical Devices and Connected Health

Explore the transformative impact of medical robots in healthcare. Discover how advanced medical devices are enhancing surgical precision, patient care, and overall healthcare outcomes with cutting-edge robotic technology.

Transforming Healthcare: The Role of Medical Robots in Modern Medical Devices

Discover how artificial intelligence (AI) is revolutionizing diagnostics in medical devices, enhancing accuracy, efficiency, and patient outcomes. Learn about cutting-edge AI applications, benefits, and the future of diagnostic technology.

Revolutionizing Diagnostics: The Power of AI in Medical Devices

Learn how global standards in medical devices ensure safety, enhance patient engagement, and improve health outcomes. Discover why these standards are crucial for medtech innovation and global healthcare success.

Global Standards in Medical Devices: Transforming Patient Engagement and Outcomes

Navigate the intricate web of regulations, certifications, and cybersecurity in the booming field of the Internet of Medical Things (IoMT). Explore global standards and safeguard your tech innovation with expert insights. Dive into our comprehensive guide now.

The Internet of Medical Things (IoMT): Regulations, Certifications, Cybersecurity, and Global Standards

Stay ahead with the latest wearable medical device trends in 2024! Discover the cutting-edge advancements in real-time health monitoring, cybersecurity measures, and data privacy protocols. Learn how innovations in sensor technology, user-centric design, and interoperability are shaping the future of healthcare. Ensure your devices meet regulatory standards and market demands for long battery life and seamless integration. Explore how wearable health tech is revolutionizing patient care and personal wellness. Dive into the essential considerations for manufacturers to thrive in this dynamic industry.

Wearable Medical Device Trends in 2024

Discover the ultimate guide to launching your medical device in the US & EU markets! Learn strategic steps for regulatory approval, market entry tactics, and effective growth strategies to ensure your product’s success. Navigate complex regulations with ease and drive your medical device to market dominance!

Launch Medical Device to Market in US & EU

Discover the transformative impact of artificial intelligence in medicine. Our comprehensive guide delves into the key benefits, cutting-edge applications, and future trends of AI in healthcare. Ideal for medtech innovators and healthcare professionals looking to leverage AI for improved patient outcomes and operational efficiency.

Exploring Artificial Intelligence in Medicine: Benefits and Applications

Artificial Intelligence in Medicine: Benefits and Applications

Unlock the essentials of medical device labeling with our comprehensive guide. Explore best practices and crucial regulatory considerations to ensure compliance and clarity in this critical aspect of healthcare technology.

Medical Device Labeling: Best Practices and Key Regulation Considerations

Medical Device Labeling Best Practices

Unlock the essentials of IEC 81001-5-1 and enhance cybersecurity for your medical devices. Our detailed guide explores the latest standards, implementation strategies, and practical tips to protect patient data and device functionality. Ideal for medtech startups and professionals aiming to stay ahead in the rapidly evolving landscape of medical device security.

Understanding IEC 81001-5-1: Cybersecurity in Medical Devices

IEC 81001-5-1 Cybersecurity in Medical Devices

Discover everything you need to know about AAMI SW96 Medical Device Security. Our comprehensive guide covers essential standards, best practices, and actionable steps to safeguard your medical devices against cyber threats. Perfect for medtech innovators and professionals dedicated to securing healthcare technology.

AAMI SW96 Medical Device Security: Everything you need to know

AAMI SW96 Medical Device Security

Optimize project visibility and accountability with our Traceability Matrix solutions. Achieve precision and compliance for streamlined project management

What is a Requirement Traceability Matrix (RTM) ?

Traceability Matrix

Stay ahead in the medical technology industry with our in-depth guide to In Vitro Diagnostic Regulation (IVDR). Learn about the latest requirements, key compliance strategies, and how to ensure your diagnostic devices meet EU standards. Perfect for medtech startups and established companies aiming to navigate the complex regulatory landscape with ease.

Comprehensive Guide to In Vitro Diagnostic Regulation (IVDR) Compliance

Create your Quality Management Plan effortlessly with our step-by-step guide. Learn the simplest methods to ensure top-notch quality in your projects. Ideal for Medical Device Companies looking to streamline their quality management processes.

Quality Management Plan - Simplest way to create yours.

Master the art of structuring your technical file for medical devices with our comprehensive guide. From regulatory requirements to essential documentation, we break down everything you need to ensure compliance and streamline your approval process. Perfect for startups and seasoned developers alike, this resource will help you navigate the complexities of the medical device industry with confidence.

How to structure your technical file for your Medical Device

Learn the importance of ISO 27001 certification for managing information security and integrating it into your QMS

How we integrated ISO 27001 requirements into our QMS ?

Discover the essence of Requirements Management with our comprehensive guide. Unravel the intricate process of gathering, documenting, and tracking requirements to ensure project success. From software development to engineering projects, grasp the fundamentals of effective requirement management practices. Elevate your understanding and optimize your workflow with expert insights and strategies. Explore the power of Requirements Management and unlock the key to project excellence today.

What is Requirements Management?

What is Requirements Management in Medical Devices.

Learn why a Requirements Traceability Matrix (RTM) is indispensable for seamless project management and software development. Unlock the key to enhanced collaboration, transparency, and efficiency in your tech endeavors.

Unveiling the Power of Requirements Traceability Matrix (RTM)

What Is a Requirements Traceability Matrix.

Crafting a robust Statistical Analysis Plan (SAP) is crucial in clinical trials to ensure accurate interpretation of data. Our expert team develops comprehensive SAPs, integrating advanced statistical methods tailored to your trial's objectives. Trust us for meticulous planning, implementation, and analysis, ensuring regulatory compliance and scientific rigor in your clinical research endeavors.

Statistical Analysis Plan in Clinical Trial

Unlock the ultimate resource for PMA (Pre-Market Approval) information on medical devices with our comprehensive database. Dive deep into regulatory insights, product specifications, and approval statuses for a seamless journey through the approval process. Stay ahead of the curve with real-time updates and invaluable data to guide your medical device development. Explore our PMA database today and streamline your path to market success.

PMA Database for Medical Devices

Craft clear and concise Instructions for Use (IFU) with our expert guidance. Enhance user comprehension and product safety with meticulously written instructions tailored to your medical device. Navigate regulatory requirements seamlessly while optimizing usability and compliance. Elevate your IFU writing process for enhanced user experience and regulatory adherence.

How to write Instructions for Use (IFU)?

How to write Instructions for Use (IFU)

Unlock the intricate world of Design Control in Medical Devices with our comprehensive guide. Dive deep into essential principles, regulations, and best practices to ensure safety, efficacy, and compliance. From concept to market, navigate every stage with confidence and precision. Elevate your understanding and mastery of Design Control for a seamless journey in medical device development.

Design Control in Medical Device : A Complete Guide

Design Control in a Medical Device : A Complete Guide

Unravel the distDiscover how Matrix Requirements helps companies streamline FDA approval, ensuring compliance and faster time-to-market for Medical Device software. Learn more today.inction between Design Verification and Design Validation in the realm of Medical Devices. Explore their critical roles in ensuring product safety and efficacy, understand regulatory requirements, and optimize your development process. Empower your team with clarity on these essential concepts for successful medical device development.

Effortlessly Navigate FDA Approval with Matrix Requirements | Proven Success

Matrix customers lead the way in FDA case studies

Unravel the distinction between Design Verification and Design Validation in the realm of Medical Devices. Explore their critical roles in ensuring product safety and efficacy, understand regulatory requirements, and optimize your development process. Empower your team with clarity on these essential concepts for successful medical device development.

Design Verification vs. Design Validation in Medical Device

Design Verification vs. Design Validation in Medical Devices

Delve into the world of IEC 82304 with our definitive guide. Explore the intricacies of Software as a Medical Device (SaMD) standards, understand compliance requirements, and navigate the complexities of medical software development with confidence. Start your journey to regulatory compliance and safe medical technology innovation now.

IEC 82304: Guide to Software as Medical Device

Unlock the power of eCFR with our comprehensive guide. Explore everything you need to know about electronic Code of Federal Regulations (eCFR), its features, benefits, and how it revolutionizes access to federal regulations. Start navigating regulatory compliance effortlessly today.

eCFR : A Complete Guide

Mastering eCRFs: Your Comprehensive Handbook for Clinical Data Excellence

Discover the essence of Training Management: Learn how it streamlines learning initiatives, enhances employee development, and optimizes organizational . Dive into its significance and best practices here.

What is Training Management?

What is Training Management

Unlock the distinctions between ALM (Application Lifecycle Management) and PLM (Product Lifecycle Management) with our comprehensive guide. Discover how each system optimizes processes and drives innovation in your organization.

What are the differences between ALM and PLM?

What are the differences between ALM and PLM

Demystify FDA Form 483 with our comprehensive guide. Discover everything you need to know about this crucial regulatory document, ensuring compliance and smooth operations for your medical device or pharmaceutical manufacturing.

FDA Form 483: Everything you need to know

Dive into our comprehensive guide to ISO 14155:2020 for Medical Devices. Explore the latest standards and requirements to ensure seamless compliance and enhance the quality of your medical device clinical investigations.

Guide to ISO 14155:2020 for Medical Devices

ISO 14155:2020 Explained: Navigating the Landscape of Medical Device Clinical Investigations

Unlock the distinction between document control and document management with our insightful guide. Learn the crucial differences that empower efficient workflow management and regulatory compliance.

Document control vs. document management : The key differences you must know.

Explore the nuances between ISO 13485 and ISO 9001 with our detailed breakdown. Discover the key differences that define quality management and regulatory compliance in medical devices versus general industries.

ISO 13485 vs ISO 9001: All the differences

Streamline your operations with our comprehensive guide to Standard Operating Procedures (SOPs). Discover how SOPs enhance efficiency, ensure consistency, and maintain compliance across your organization.

Standard Operating Procedure (SOP) : A Guide

Navigate the complexities of UDI database management with confidence. Dive into our ultimate guide, packed with expert tips and insights to help you master UDI compliance effortlessly.

Mastering UDI Database: Your Ultimate Guide

21 CFR Part 812 outlines regulations concerning the investigational use of medical devices, ensuring their safety and effectiveness before they are widely marketed. This section of the Code of Federal Regulations (CFR) by the Food and Drug Administration (FDA) establishes requirements for clinical investigations of medical devices, including protocols, monitoring, reporting, and record-keeping. Compliance with 21 CFR Part 812 is crucial for manufacturers and researchers conducting studies to bring new medical devices to market.