Deanna Anderson, Author at Lachman Consultant Services, Inc.

Close up of hand touching smartwatch with health app on the screen, gadget for fitness active lifestyle.

The Future of Devices and Impact on Health Outcomes

By Deanna Anderson Nov 08, 2024 Device FDA Regulatory Affairs

The 2024 MedTech Conference in Toronto provided some great insights on what the future of medical devices can offer, particularly when utilizing AI technology. One area making great progress is the use of wearables. Who knew my Apple watch could be so useful?! There were multiple presentations on pairing wearable devices with mobile apps. This […]

Aug

Navigating Future Quality and Regulatory Challenges for Medical Device Companies - Lachman Blog

Navigating Future Quality and Regulatory Challenges for Medical Device Companies: Understanding the FDA Quality Management System Regulation (QMSR)

By David Day and Deanna Anderson Aug 27, 2024 Compliance Device FDA Regulatory Affairs

The FDA’s long-awaited QMSR will be released in February 2026. The amended 21 CFR 820 will incorporate by reference the Quality Management System (QMS) requirements of the 2016 edition of ISO 13485. We will explore the key differences between an FDA inspection and a notified body audit as well as the distinctions between ISO 13485 and the QMSR. […]

The Future of Devices and Impact on Health Outcomes

Navigating Future Quality and Regulatory Challenges for Medical Device Companies: Understanding the FDA Quality Management System Regulation (QMSR)

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