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MedTech Intelligence

Volume 13 Issue No. 37


FDAFDA Reorg Establishes Office of Digital Transformation

By MedTech Intelligence Staff

The agency has realigned information technology, data management and cybersecurity functions, and established a new office reporting directly to the FDA commissioner.



DNVIncreased EU Clinical Requirements

September 21, 2021 11:00AM-12:00PM ET

The Medical Device Regulation 2017/745 introduced higher pre- and post-market clinical requirements on manufacturers of all classes of devices. All these requirements remain challenging for the various stakeholders due to the missing experience in their implementation. During this webinar we will be able to share with you the first experience with the implementation of the regulatory requirements and the feedback of a designated notified body on the first submissions according to the new legislation.

Featured Articles

Patient Engagement and Connected Medical Devices Series: Lifestyle Integration for Medical Devices

By Adrian Pittman, LinkedIn; Bernhard Kappe and Randy Horton, Orthogonal

Devices by themselves don’t improve outcomes. Better lifestyle integration is key to driving changes in patient compliance—embedding sensors into the sorts of devices people can use every day to increase opportunities for passive biometric capture and to facilitate therapeutics.

IoMT, Connected Devices Introduce More Cyber Threats into MedTech and Healthcare Organizations

By Maria Fontanazza, Editor-in-Chief

To change the landscape of cyber threats in healthcare, companies must prioritize designing security into devices.


Effective Manufacturing Test Strategies to Improve the Quality of Connected Medical Devices

By Sook Hua Wong, Keysight Technologies

Adding wireless connectivity to medical devices brings convenience to patients, and can facilitate more effective healthcare delivery and lower healthcare costs. Its success depends on the ability of manufacturers to produce reliable, connected products that do not fail prematurely in the field.

Evidence Partners Incorporated - Evidence Matters '21

Diagnostic and Monitoring Solutions Define Smart MedTech
Industry Trends

By Saloni Walimbe, Global Market Insights, Inc.

Increased awareness during the COVID-19 crisis and public efforts to strengthen the development of healthcare technologies has boosted the smart medical devices sector.


Developing Robust AI Medical Products Requires Facing
Data-Driven Truth

By Zhenxue Jing, Ph.D., Hologic

As more medtech companies take advantage of the game-changing technology to innovate and advance products, they must anticipate the need to obtain trustworthy, evidence-based comprehensive data—and be prepared to do their own due diligence to verify the chain of evidence and meet increasingly stringent regulatory requirements.


SalesforceModernizing Your MedTech Selling Process

Recorded: August 4, 2021 - Sponsored by Salesforce

“COVID only helped set the wind in our sails”, said Michael Allen, AVP of Sales and Service, Dynarex, when asked about the impact of COVID to his business processes. During this On-Demand Webinar, you will be able to listen and learn how Dynarex, a medtech company was able to increase sales by improving deal time to addressing revenue leakage.

Watch Now!

Cybersecurity by Design in Medical Devices

By Dr. Abtin Rad, TÜV SÜD Product Service GmbH

Medical devices and medical software are becoming increasingly connected to hospital networks, other medical devices or the Internet. As a result, manufacturers and developers are required to consider cybersecurity from the very early stages of development. This in turn necessitates comprehensive risk management along the entire lifecycle of a device.

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MedTech Library

Seizing the Customer Experience Opportunity in Life SciencesSeizing the Customer Experience Opportunity in Life Sciences

Sponsored By Salesforce

Salesforce and Harvard Business Review (HBR) have teamed up to dive deep on why improving customer experience is top of mind for life science organizations in “Seizing the Customer Experience Opportunity in Life Sciences” whitepaper.

Top 6 uses for video on medical device assembly lines

Sponsored By Drishti Technologies, Inc.

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