Language Scientific Outlines What “Quality” Means in Medical Device Labeling Translation

January 13, 2026 - PRESSADVANTAGE - In the highly regulated field of medical device labeling translation, ensuring that ...
MD&M East

Wireless Medical Devices: Satisfying Radio Requirements

Integrated Circuits Understanding radio protocols and requirements is the first step in successfully using wireless communication in medical applications. Carl Falcon Table I. Wireless system ...
GlobalData on MSN

FDA announces regulatory exemptions for ‘non-medical grade’ devices

FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less ...
JD Supra

State Licensing Spotlight – Prescription medical device manufacturers & distributors: Regulatory considerations applicable to medical devices versus drugs

State licensing for prescription medical device manufacturers and distributors is a complex and evolving landscape. While FDA oversees federal regulations, individual states impose their own licensing ...
JD Supra

FDA (Finally) Harmonizes Medical Device Manufacturing Requirements With ISO

On February 2, 2024, the US Food and Drug Administration (FDA) published a much-awaited final rule: the Quality Management System Regulation (QMSR). 1 By issuing this rule, FDA amended the medical ...
The National Law Review

FDA Finalizes Revised Medical Device Quality System Requirements, Issues Remote Regulatory Assessments Guidance

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
ConsumerAffairs

FDA relaxes rules for wearable health devices

The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.
Fieldfisher

Preparing for new pre-market requirements in Great Britain: what MedTech companies need to know

Great Britain is entering a new era of MedTech regulation, with major pre-market changes expected that are designed to ...
Supply Chain

Implementing D365 for Alignment with Your Medical Device Requirements: A Webinar Exploration

Join our team of experts as we explore the extensive capabilities of D365 with Alithya 365 Enhanced Quality and Compliance, providing your medical device organization with the tools and insights ...