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

MedTech Intelligence

Volume 14 Issue No. 24

 

Garrett Schumacher, ValentiumThe Shifting Sands of Medical Device
Cybersecurity Regulation

By Garrett Schumacher, Valentium

Old justifications or business reasons for security gaps are obsolesced. We need robust medical device cybersecurity, but we need it in a manner that is workable by both MDMs and HDOs.

 

SPONSORED RESOURCE

Preparing for Europe’s New Medical Device RegulationPreparing 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.

Download to learn more

Featured Articles

FDA Issues Final Guidance on Technical Performance Assessments of Quantitative Imaging in Premarket Submissions

By MedTech Intelligence Staff

Manufacturers preparing premarket submissions should provide performance specifications for the quantitative imaging functions, supporting performance data, and sufficient information for the end user to obtain, understand and interpret the values provided.

Soapbox

The Need for Global Standards in Digital Health Platforms

By Leo Petrossian, Nile

The COVID-19 pandemic exposed the necessity of virtual care and revealed its possibility as a more efficient means of administering treatment in an overwhelmed and understaffed infrastructure. Its fast-paced adoption highlighted the need for global standards and third-party certifications.

Huma.ai - HUman + MAchine

Can Technology be an Equalizer?
Using Innovation to Tackle Healthcare Disparities

By Davidi Vortman, UltraSight

Combining imaging technology with artificial intelligence can help address challenges in healthcare disparities as well as in patient care.

Evidence Partners and Akra Team Join Forces To Help Medical Device Companies Accelerate Completion of EU MDR and IVDR Submissions

By MedTech Intelligence Staff

The partnership brings together Evidence Partners' literature review platform, DistillerSR, and Akra Team's strategic regulatory services.

Connected Care Webinar Series

Rethinking the Medical Device Supply Chain

June 16, 2022 12:00 pm - 2:30 pm EST
Complimentary Registration

There have always been supply chain disruptions, but the COVID-19 pandemic starkly highlighted the fragility of many supply chains and the dangers to public health created when medical device manufacturers cannot produce or deliver their products. This web event episode features presentations, discussions, and a Q&A session by industry thought leaders and other experts in supply chain strategy.

Register Now!
MedTech Library

6 Requirements for Medical Device Manufacturers in 20226 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.

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

Sponsored By Innovaccer

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.

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

7 Principles of Product-Centric Quality Management: A Guide for Medical Device Innovators7 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.

Unified Medical Imaging Solutions: The Next Evolution in ImagingUnified Medical Imaging Solutions:
The Next Evolution in Imaging

Sponsored By Arrow and Dell Technologies

Effective data management and processing challenges need to be addressed seamlessly for modern imaging solutions to facilitate quick and precise diagnosis, augment business workflow, and improve patient care.

The Rise of Implantable Devices

Sponsored By AMETEK-COINING

All Available Resources
Upcoming Events & Webinars

June 16, 2022 – 12:00 pm – 2:30 pm

Rethinking the Medical Device Supply Chain

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