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MedTech Resource Library

Resources Available

REGULATORY REPORT 2024: Managing Global Regulatory Strategy & Compliance: Assessing Status, Gaps & Needs

An April 2024 survey of medical device regulatory professionals illustrates potential regulatory fatigue. See how resource constraints, ever changing global policy, and an underutilization of technology/digital process are impacting internal burden and fatigue and where implementing new regulatory strategies, upgrading organizational expertise, adding outsourced regulatory services are helping teams cope.

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RIM Buyers Guide

RIM Buyers Guide for MedTech

If you’re considering a RIM system, it’s critical to determine the right scope, software capabilities, and balance between cost and value. Learn how to evaluate each piece with this RIM buyer’s guide for medtech.

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EU MDR Checklist

EU MDR: Technical Documentation Checklist For Medical Device Manufacturers

Explore our EU MDR Checklist designed to help you navigate EU MDR compliance. This practical tool guides you through essential steps to adapt your processes and ensure documentation meets regulatory standards. Start your compliance journey with confidence.

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Supply Chain Guide

The Essential Guide to Strategic Supplier Management for Medical Devices

Sponsored By Velosio

Medical Device Supply Chain Struggles? Download our FREE guide and discover how strategic supplier management builds resilience for a reliable flow of critical devices. We delve into the industry's unique challenges – strict regulations, quality needs, and constant innovation.

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Addressing engineering challenges in point-of-care diagnostic devices

Addressing engineering challenges in point-of-care diagnostic devices

Sponsored By Flex

Discover what to consider when designing and manufacturing point-of-care diagnostic devices, including ensuring measurement accuracy and reliability, user-friendly operation, and scalable production with validated manufacturing processes.

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Leveraging Technology to Optimize MDR Compliance Outsourcing & Partnership

Leveraging Technology to Optimize MDR Compliance Outsourcing & Partnership

Sponsored By Celegence

Download this case study for insights on optimized regulatory processes via tech-enabled services from Celegence. Acumed made their MDR compliance a success by boosting efficiency, saving time, and streamlining collaboration.

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The ultimate guide to the EU MDR and IVDR GSPR, 2nd Edition

The ultimate guide to the EU MDR and IVDR GSPR, 2nd Edition

Sponsored By Rimsys

This comprehensive ebook breaks down the general safety and performance requirements for both the EU MDR and IVDR and includes tables comparing the EU MDD and IVDD Essential Principles with MDR and IVDR General Safety and Performance Requirements.

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Crossing the eSTAR Chasm- The First MedTech Benchmark Report on FDA's 510(k) eSTAR Mandate

Crossing the eSTAR Chasm – The First MedTech Benchmark Report on FDA’s 510(k) eSTAR Mandate

Sponsored By Essenvia

In this groundbreaking report, Essenvia shines a first-ever light on regulatory professionals' preparedness, benchmarks, and best practices for embracing eSTAR and overcoming the challenges MedTech companies face in adopting the new mandate.

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5 eSTAR Challenges MedTech Regulatory Teams Must Overcome

5 eSTAR Challenges MedTech Regulatory Teams Must Overcome

Sponsored By Essenvia

This paper will educate and prepare medical device manufacturers, regulatory affairs leaders, and regulatory consultants to effectively transition their processes, resources, and operations to seamlessly adopt the eSTAR as the new submission standard.

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How redesign can help meet sustainability demands for medical devices

How redesign can help meet sustainability demands for medical devices

Sponsored By Flex

Redesign using Design for Environment principles can help medtech companies meet sustainability demands for their devices. See how to analyze and use eco-smart designs that account for sustainable materials, product durability, and improved energy efficiency.

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How to Achieve Optimal Weighing Performance with Lab Balances

How to Achieve Optimal Weighing Performance with Lab Balances

Sponsored By Sartorius

Are you interested in how to achieve optimal weighing results in your medical devices production? Follow the subsequent tips and profit from highly reliable weighing results .

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Better device outcomes through better data

Better device outcomes through better data

Sponsored By Truveta

In this whitepaper, learn how MedTech companies can accelerate R&D, monitor products post-market, and improve patient outcomes with clean, complete data from 30+ US health systems and access specific device information from more than 150,000 devices.

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The Emergence of Lateral Flow Assays in Diagnostics

The Emergence of Lateral Flow Assays in Diagnostics

Sponsored By Sartorius

Hasret Altan-Martin from Sartorius talks about the ongoing emergence of lateral flow assays (LFAs) in diagnostics. Learn why you should choose Unisart®CN membranes and how their superior sensitivity can change the future of LFA’s. Read more now!

Read More

Regulatory strategy as a competitive advantage

Regulatory strategy as a competitive advantage

Sponsored By Rimsys

Medtech regulatory teams have traditionally been treated as operational cost centers with limited investment in people, tools, or digital transformation. This ebook explores how stronger regulatory/revenue alignment can power competitive advantages.

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Terumo Enables Global Collaboration and Clinical Excellence for Groundbreaking Medtech Research

Terumo Enables Global Collaboration and Clinical Excellence for Groundbreaking Medtech Research

Sponsored By Veeva Medtech

Terumo, global leader in medical technology, transforms to a unified, digital approach to manage global clinical trials and operations. Read this article to learn about the approach, processes, infrastructure changes, and impact on the business.

Read More

2023 MedTech Regulatory Performance Report

2023 MedTech Regulatory Performance Report

Sponsored By Rimsys

See insights and process benchmarks for medtech regulatory affairs from a new survey of 200 regulatory professionals across North America and Europe. The report explores regulatory staffing, workload, compliance issues and costs, and the role of technology and digital transformation.

Read More

Johnson and Johnson Standardizes Global Quality on ETQ Reliance

Johnson and Johnson Standardizes Global Quality on ETQ Reliance

Sponsored By etq part of Hexagon

The case study features several best practices that are useful to others who are looking for a single quality management platform on which to standardize and harmonized quality processes and outcomes across multiple locations or business units.

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Supplier Quality as Competitive Advantage: Perspectives from PwC, Cardinal Health, and Veeva

Supplier Quality as Competitive Advantage: Perspectives from PwC, Cardinal Health, and Veeva

Sponsored By Veeva Medtech

To address today’s supply chain challenges and ensure quality products it’s critical to have a robust quality management system. Download this article featuring PwC and Cardinal Health for insights on building a business case and supporting digital transformation goals.

Read More

AI Medical Device Software Under the MDR

AI Medical Device Software Under the MDR

Sponsored By DNV

This paper reviews some key aspects of safety and performance assessments of AI medical device software according to the existing regulation (EU) 2017/745 (MDR) ahead of the upcoming regulatory updates and standards publication. It also provides a review of requirements to be addressed in order to bring an SaMD to market.

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Symmetry Surgical Uses ETQ Reliance Out-of-the-Box to Streamline, Enhance Quality

Symmetry Surgical Uses ETQ Reliance Out-of-the-Box to Streamline Enhance Quality

Sponsored By etq part of Hexagon

Symmetry Surgical® is a leading healthcare technology and solutions provider of high-quality surgical instrumentation, a full-line electrosurgery portfolio, and minimally invasive surgical devices. The company needed to adhere to changing FDA and other regulations while simultaneously protecting its brand value.

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Predictive Quality for Medical Devices

Predictive Quality for Medical Devices

Sponsored By Critical Manufacturing

Wouldn’t it be great to know and be able to automatically release products when every process stayed within the specified envelope? And to sample or test only as much as a particular process requires, no more or less? Those are the promises of predictive quality. Get to know what executives from Medtronic, B Braun, Jabil and Ultradent have to say about it.

Read More

Increase agility and innovation with PLM for medical devices

Increase agility and innovation with PLM for medical devices

Sponsored By Siemens

Siemens PLM for medical devices is an integrated end-to-end product development system that tackles complexity and regulation through re-use, content capture and collaboration.

Read More

The Impact of Covid-19 on the Medical Device Supply Chain

The Impact of Covid-19 on the Medical Device Supply Chain

Sponsored By Loftware, Inc.

It’s no secret, the medical device supply chain was significantly impacted by the COVID-19 pandemic. Discover how leading medical device manufacturing companies adapted to meet the changing demands with labeling to ensure uptime.

Read More

Drive Healthcare Transformation with Enterprise-Level Infrastructure

Drive Healthcare Transformation with Enterprise-Level Infrastructure

Sponsored By Arrow and Dell Technologies

Learn the key considerations and best-fit solutions for healthcare transformation that optimize operations for providers and ensure better outcomes for patients. Discover how the Arrow Electronics and Dell Technologies OEM Solutions portfolio can match any healthcare need.

Read More

Adapting to COVID-19 with simulation in the medical device industry

Adapting to COVID-19 with simulation in the medical device industry

Sponsored By Siemens

Learn how medical device manufacturers are using simulation to enhance their design process to help fight COVID-19 and continuously innovate.

Read More

Preparing for Europe’s New Medical Device Regulation: The Essential Guide to EU MDR Compliance

Preparing for Europe’s New Medical Device Regulation: The Essential Guide to EU MDR Compliance

Sponsored By PTC Arena

Download our whitepaper today as we provide the key steps to making a successful MDR transition, as well as some insights on how an enterprise quality management system (eQMS) solution can help simplify compliance.

Read More

6 Requirements for Medical Device Manufacturers in 2022

6 Requirements for Medical Device Manufacturers in 2022

Sponsored By Rootstock Cloud ERP

Discover the 6 key requirements to consider when executing your digital transformation strategy and learn how to turn uncertainty and disruption into a model for sustainable growth.

Read More

Data Curation: Enabling your Digital Strategy with a Comprehensive Data Strategy

Data Curation: Enabling your Digital Strategy with a Comprehensive Data Strategy

Sponsored By Innovaccer

With the changing market landscape, heightened patient expectations, pricing pressures, and healthcare reforms, life sciences companies need to quickly adapt to enable high-quality care by embracing digital transformation. Through this whitepaper look under the hood to see how Innovaccer can help life-science companies address these challenges and move towards the digital disease management ecosystem.

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7 Principles of Product-Centric Quality Management: A Guide for Medical Device Innovators

7 Principles of Product-Centric Quality Management: A Guide for Medical Device Innovators

Sponsored By PTC Arena

Read this eBook to learn how to overcome process delays, compliance risks, and barriers that impede innovation.

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Launching your medical device: A strategy & execution cross-functional guide

Launching your medical device: A strategy & execution cross-functional guide

Sponsored By Definitive Healthcare

Learn how the experts launch their medical devices. Definitive Healthcare’s eBook cowritten by Carl Zeiss Meditec Inc. is packed with checklists and descriptions of all major pre-launch action items each team in your org needs to complete to successfully launch your device.

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Unified Medical Imaging Solutions: The Next Evolution in Imaging

Unified Medical Imaging Solutions: The Next Evolution in Imaging

Sponsored By Arrow and Dell Technologies

Move from disconnected PACS and VNA instances to a unified architecture that enables data analysis in real-time and seamlessly shares data with all the stakeholders. Learn about the Arrow Electronics and Dell Technologies OEM Solutions portfolio for unified medical imaging solutions.

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The Rise of Implantable Devices

The Rise of Implantable Devices

Sponsored By AMETEK-COINING

In this whitepaper, we'll take a closer look into the state of the medical device industry, in general, and the rise of implantable devices, specifically. We'll touch on how those devices are changing people's lives for the better and what to consider when choosing the right materials that go into making these devices.

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Medical device design control with Siemens Digital Industries Software

Medical device design control with Siemens Digital Industries Software

Sponsored By Siemens

The goal of this paper is to dive into the nuanced topics of a requirements management and tracking solution. We will explore the broader use of our PLM tool for concept management throughout their lifecycle.

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The Post-Market Gambit: After EU MDR and IVDR: A Systematic Compliance Framework for Driving MedTech Innovation

The Post-Market Gambit: After EU MDR and IVDR: A Systematic Compliance Framework for Driving MedTech Innovation

Sponsored By Huma.AI

Based on extensive research and expert interviews, this 60-page ebook explores the challenges, costs, and opportunities that EU MDR and IVDR have created. Moreover, it offers a solution and vision for a New Era of Post-Market Intelligence.

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Connected Health Consumer Report (2nd ed.): Trust in a new era of health

Connected Health Consumer Report – Trust in a new era of health

Sponsored By Salesforce

58% of consumers say interactions with medical technology companies feel transactional. Read this report and see what 12,000 global health consumers say they would like from medtech organizations when it comes to building relationships centered on trust and communication.

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How to Address the Top Four Labeling Challenges Facing Medical Device Manufacturers

How to Address the Top Four Labeling Challenges Facing Medical Device Manufacturers

Sponsored By Loftware, Inc.

Discover the four key challenges facing medical device manufacturers and learn how modern, cloud-based label management helps companies tackle these challenges and optimize their operations for the global marketplace.

Read More

The Ultimate Guide to Next-Generation Supplier Management

The Ultimate Guide to Next-Generation Supplier Management

Sponsored By ComplianceQuest

Technology is not only an enabler of supply chain management but is fast disrupting trends and practices. Think IoT, industrial robotics, other embedded systems on the shop floor, data-driven inventory optimization, digital transformation, automation and more.

Read More

Think You Know Everything About CRM for Medtech? Think Again.

Think You Know Everything About CRM for Medtech? Think Again.

Sponsored By Salesforce

Learn how a purpose-built platform for the medtech industry can be your system of engagement to drive commercial excellence by connecting teams, surfacing commercial planning insights, and deepening patient connections.

Read More

Operational Excellence: Charting a path to operational excellence with a focus on manufacturing

Operational Excellence: Charting a path to operational excellence with a focus on manufacturing

Sponsored By Siemens

Download this white paper today and find out how operational excellence for medical devices helps enterprises go beyond the complex modern requirements of medical device manufacturing. Learn how eliminating manual DHR activities will improve resource utilization and remove errors.

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Beyond Inspection: Rethinking the role of video in manual assembly

Beyond Inspection: Rethinking the role of video in manual assembly

Sponsored By Drishti Technologies, Inc.

What if “inspection” meant more than identifying faulty or suspect units before they escape the factory? Thinking beyond inspection means infusing quality practices into every step of the assembly process.

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Empowering emerging medical device manufacturers

Empowering emerging medical device manufacturers

Sponsored By Siemens

This eBook reviews the industry trends in MDD and the unique challenges facing SMB. The requirements for a digital infrastructure that addresses those challenges are detailed, and the Siemens solution developed according to those requirements is explained.

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Accelerating growth for emerging medical device and diagnostic industry SMB manufacturers

Accelerating growth for emerging medical device and diagnostic industry SMB manufacturers

Sponsored By Siemens

This is an infographic focusing on Small-to-Medium sized businesses (SMB), which are the emerging manufacturers in the medical devices market.

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Top 6 uses for video on medical device assembly lines

Top 6 uses for video on medical device assembly lines

Sponsored By Drishti Technologies, Inc.

The video revolution has come to medical device assembly. Here are the top six ways leading Class II/III device manufacturers are using video to transform the effectiveness of everyone on and around the line — including the line operators themselves.

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Reduce Your Medical Device Time-to-Market with CPQ Software

Reduce Your Medical Device Time-to-Market with CPQ Software

Sponsored By Experlogix, LLC

Specifically designed for the Medical and Mobility industry’s complex and custom products, discover how CPQ (configure, price, quote) software can help your company save money, increase customer satisfaction, and generate real ROI. Download our latest datasheet to learn more about how CPQ software can help your business.

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Deliver Accurate Medical Device Configurations and Quotes with CPQ

Deliver Accurate Medical Device Configurations and Quotes with CPQ

Sponsored By Experlogix, LLC

CPQ (configure, price, quote) software is designed to help medical device and mobility manufacturers accelerate the quoting and proposal generation process, eliminate mistakes, and easily guide users through the most complex pricing and quoting.

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How medical device companies can create end-to-end connectivity for in-hospital equipment

How medical device companies can create end-to-end connectivity for in-hospital equipment

Sponsored By S3 Connected Health

Data insights collected on connected medical devices can bring many benefits for vendors, healthcare providers, and patients; from improving healthcare outcomes to reducing the cost of care and device maintenance. This whitepaper details the key steps to consider when creating a secure, scalable connectivity ecosystem based around medical equipment in the hospital environment.

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The Business Value of Cybersecurity in MedTech

The Business Value of Cybersecurity in MedTech

Sponsored By Irdeto

Build a secure line of defense for your devices against a growing range of cyberattacks. Irdeto's report in collaboration with Censuswide has identified clear ways for Health companies to improve customer and patient outcomes, make better data-driven decisions, increase trust, and generate more revenue.

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BSI - MDR Documentation Submissions: Best Practices Guidelines

MDR Documentation Submissions: Best Practices Guidelines

Sponsored By bsi

The two most frequent reasons for delays to technical documentation reviews are: 1) BSI has not been provided with all of the information needed for the review; 2) The information is present within the technical documentation, but is difficult to locate.

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Explaining IVD Classification Issues

Explaining IVD Classification Issues

Sponsored By bsi

To comply with the Regulation on in vitro diagnostic medical devices (2017/746) (IVDR) manufacturers must classify their in vitro diagnostic (IVD) devices in accordance with the rules set out in Annex VIII of the Regulation. There are some significant differences between the classification systems for medical devices and IVD medical devices under the new regulations.

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Telemedicine Cybersecurity Report: Android Patient-Facing Mobile Apps

Telemedicine Cybersecurity Report: Android Patient-Facing Mobile Apps

Sponsored By Irdeto

In this new whitepaper, Irdeto identified five B2C patient-facing Android telemedicine mobile apps that offer both synchronous and asynchronous virtual visit experiences to US consumers and are downloadable via Google Play and performed an extensive cybersecurity threat risk analysis of these apps.

Read More





Learning Center

  • HD PLM Webinar – Smarter Decisions, Better Products for Orthopedic and Medical Device Development
  • Integrated Quality with PLM
  • Manage Requirements and Traceability with a Unified PLM System
  • How to Eliminate the Biggest Time Wasters for Engineers: An Energist Success Story
  • Future Test - A Case Study
  • Bausch+Stroebel - A Case Study
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  • Designing Medical Devices to Improve Patient Outcomes: An AMR Report

More Resources

  • Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions
  • Pharmaceutical and Medical Device Sector Guidance for Product Life Cycle Accounting

Featured Articles

November 27, 2024
sustainable design

From design to disposal:
Reducing the footprint of single-use drug delivery devices

By Alex Fong

How can drug delivery devices manage competing priorities - reducing overall carbon footprint without expense to patient and practitioner safety or treatment efficacy. Sustainability strategies must account for commercial and budgetary pressures.

July 8, 2024
LDT Development

The FDA’s final lab developed test rule places new burdens on manufacturers

By Laura Housman

Diagnostic manufacturers and pharmaceutical sponsors with therapeutics that rely on biomarker identification or companion diagnostics should adjust their commercialization and partnership strategies to fit the new regulatory environment.

January 22, 2023
Rama Chellappa

Instilling Trust in AI

Rama Chellappa, PhD, John Hopkins University Bloomberg Distinguished Professor in electrical, computer, and biomedical engineering, and co-author of "Can We Trust AI?" looks at the promise of AI in health care and how we can best utilize this extraordinary tool to save lives and improve health equity.

October 12, 2020
Arlen Ward, System Insight Engineering

Computer Modeling and Simulation Helps MedTech Developers Bring Innovation to Reality

By Maria Fontanazza

No longer just “the big company advantage,” Arlen Ward discusses how CM&S is an accepted and viable device industry path to market for large and small medical device makers alike.

September 2, 2020
Checkbox

Cybersecurity, COVID-19 and EU MDR Hot Topics of the 2020 MedTech Summer

By MedTech Intelligence Staff

Although the full impact of COVID-19 is uncertain, one sure thing is that industry continues to crave information to help them navigate EU MDR.

June 15, 2020
Abbott FreeStyle Libre 2

FDA Clears Abbott’s Continuous Glucose Monitoring System for Use in Children

By MedTech Intelligence Staff

The FreeStyle Libre 2 now has indications for children ages four and older.

May 25, 2020
FDA

In Face of COVID-19, FDA Updates Adverse Event Reporting Guidance Document

By MedTech Intelligence Staff

The goal of the guidance is to ensure that manufacturers are prepared to report adverse events during a pandemic.

March 17, 2020
N95 respiratory mask

Amidst COVID-19 Pandemic, Scams Involving Personal Protective Equipment Emerge

By MedTech Intelligence Staff

As the saying goes, if it looks too good to be true, it probably is.

View More Combination Products Articles »

  • Digital Health
  • MedTech Economics
  • Manufacturing Execution
  • Product Design & Development
  • Quality/Regulatory

Upcoming Events & Webinars

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On Demand Events & Webinars

February 26, 2025 – 2:00 pm – 3:00 pm
Are you talking to me? Communicating effectively with your Notified Body for an Accountable and Sustainable Working Relationship
January 21, 2025 – 11:00 am – 12:00 pm
Medical Device Labeling Best Practice for 2025: The Global Design Master
December 17, 2024 – 2:00 pm – 3:00 pm
Adapt, Thrive, and Lead: Insights for Global Medical Device Executives
October 29, 2024 – 10:00 am – 11:00 am
The Art of Benefit-Risk Calculation: Essential Tools for EU MDR Mastery

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