Sustainability:
Lessons from the Frontlines of Health Care

By Urvashi Bhatnagar and Jeff Thompson, MD

Under the leadership of Jeff Thompson, MD, Gundersen Health System reduced its greenhouse gases by 95% and was nationally recognized for higher quality care and lower costs. Here Dr. Thompson and Urvashi Bhatnagar, DPT, MBA, author of The Sustainability Scorecard: How Firms can Implement and Profit from Unexpected Solutions, share the strategies and organizational mindset needed to advance sustainability in health care.

Laying the Groundwork for an AI Breakthrough

By Costas Tsougarakis, Flywheel

Digital transformation requires a clear vision, buy-in at every level, and significant investment. Here are three steps to streamline the process.

Moving Beyond ASL with Design Controls and Supplier Management

Sponsored By ComplianceQuest

Design controls and supplier information are vital components to building your product’s digital thread. Learn how to add value to your device by keeping track of supplier and manufacturing controls through design, and how to build practical data structures to provide the visibility needed so your suppliers and manufactures can build high-quality products that your customers will swear by. Presenter: Tim Brown, VP of Products – PLM, ComplianceQuest.

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FDA To Host Webinar on Electromagnetic Compatibility of
In Vitro Diagnostic Devices

By MedTech Intelligence Staff

The FDA is hosting a webinar on February 2 for interested stakeholders to discuss the final guidance Electromagnetic Compatibility (EMC) of Medical Devices and its applicability to in vitro diagnostic (IVD) devices.

Intricon Launches Biosensors Center of Excellence

By MedTech Intelligence Staff

The Intricon Biosensor CoE team has expertise in high-density microelectronics, miniaturization, ultra-low power, miniature molding, firmware development, and wireless communication

Soapbox

Risk Management Is More Than a Spreadsheet

By Thomas Skogen, Aras

Mitigating risk of failure is one of the most important disciplines to perform for medical device manufacturers, and for the last couple of years, it has become an increasingly difficult discipline to master.

Featured Quote

Though the test matrix provided in ISO 10993-1:2018 is a useful tool for endpoint selection, it is not comprehensive when it comes to biological safety. Strictly adhering to this matrix may result in an incomplete safety evaluation.

— Jaishankar Kutty, Ph.D. - RQM+

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.

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.

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.

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.

Increase agility and innovation with PLM for medical devices

Sponsored By Siemens

With medical devices becoming more complex and regulatory oversight becoming stricter, it is difficult for manufacturers to deliver products effectively and maintain a competitive edge. However, there are always ways to improve innovation, speed to market and data quality while continuing to be compliant.