Instilling Trust in AI

By MedTech Intelligence Staff

Rama Chellappa, PhD, a 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.

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.

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Tackling Go-To-Market Challenges

By Michael King, IQVIA

By deploying connected intelligence systems at a global scale, teams can navigate go-to-market challenges by increasing the transparency and predictability of the complex and divergent global product registration processes.

From The Editor's Desk

Connected Care:
Overcoming Roadblocks and Identifying Opportunities

By MedTech Intelligence Staff

Leaders in digital health development and regulation look at best practices, pitfalls and what’s next for connected medical devices and technologies.

MedTech Regulatory Intelligence:
Post-Market Surveillance

Sponsored By HUMA.AI and Rimsys

Post-market surveillance has become an increasingly important area of focus in both U.S. FDA and EU regulations. In this webinar, we take a closer look at the challenges of developing sustainable post-market surveillance processes, as well as how companies are addressing these challenges and using new tools to track product safety and performance post market. With Queenita Fernandes of Medtronic, Robert Di Giovanni of Novartis, Ashley Kelleher of NSF, Adam Price of Rimsys and Lana Feng of HUMA.AI.

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FDA Seeks Input on Advancing Use of Real-World Data and Evidence

By MedTech Intelligence Staff

The FDA is asking stakeholders to submit public comments on how it should use any portion of the user fee funding that may be distributed to external organizations—other than NEST—to support premarket RWE in medical device evaluation and development.

New Cybersecurity Standards for Medical Applications

By Dr. Abtin Jamshidi Rad, TÜV SÜD

Connectivity in medical devices creates new diagnostic and treatment opportunities, yet at the same time increases the risks of cyberattacks—including their consequences for patient safety and data privacy. Now the new IEC 81001-5-1 standard provides clear technical requirements for manufacturers and developers to ensure the cybersecurity of their products across their life cycle.

Featured Quote

The Liver-Chip detected nearly 7 out of every 8 drugs that proved hepatoxic in clinical use despite having been deemed to have an appropriate therapeutic window by animal models.

— Lorna Ewert, et al. - Emulate Inc.

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.