Demystifying Regulatory Hurdles:
How to Navigate FDA Approval for AI-Enabled Medical Devices

By Jeanna Blitz, MD, and Cory Hayes, MPH,
Noridian Healthcare Solutions

Several alternatives exist to obtain FDA approval of artificial intelligence-enabled medical technology. Determining the best approach for a new device will require an awareness of each pathway’s specific requirements. An appreciation of the unique considerations for artificial intelligence-enabled technologies is another essential component of an efficient and effective application.

Misconceptions of Miniaturization (Part 3):
Smaller is Cheaper

By Nicholas Lesniewski-Laas, Sunrise Systems

Typically, costs are reduced by using less material and floor space, and eliminating any specialty equipment required for handling large or heavy parts. For miniature devices, the equation is reversed.

FDA Releases Laboratory Developed Tests Final Rule

By MedTech Intelligence Staff

“The final rule announced today aims to provide crucial oversight of these tests to help ensure that important healthcare decisions are made based on test results that patients and health care providers can trust.”

UL Certification:
A Launchpad for Product Development Excellence

By Erez Kaminski, Ketryx

Embracing certification leads to enhanced product quality, innovation, and customer trust.

Navigating the New Normal:
Achieving R&D Success in Hybrid Work Environments

By Philip Remedios and Renée Bailey, BlackHägen Design

Embracing certification leads to enhanced product quality, innovation, and customer trust.

What is Regulatory Excellence in the
Medical Technology World?

By MedTech Intelligence Marketing Staff

Regulatory excellence is now considered a pathway to innovation and sustained business growth, making it a fundamental component of success in the medical devices industry. MedTech manufacturers are fostering a culture of regulatory excellence to enhance compliance with regulatory requirements and ensure product safety, efficacy, and quality in the global marketplace.

Harnessing the Potential of Digital Quality:
Transforming Manufacturing Outcomes for Long-Term Success

By MedTech Intelligence Marketing Staff

Automation and digitization of quality processes can improve efficiency, reduce costs, and enhance product quality in manufacturing, allowing for more informed decisions that will contribute to long-term success.

Addressing engineering challenges in point-of-care diagnostic devices

Leveraging Technology to Optimize MDR Compliance Outsourcing & Partnership

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

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

5 eSTAR Challenges MedTech Regulatory Teams Must Overcome

How redesign can help meet sustainability demands for medical devices

Please visit the newest MTI Resource Center
Post-Market Surveillance

The MTI Post-Market Surveillance Resource Center provides current news and information specific to maintaining medical device post market product quality & compliance. PMS is a critical component in achieving global Regulatory Excellence to ensure medical devices remain safe, effective, and reliable for end-users.

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