DEK Strengthens Medical CNC Machining With ISO 13485 Quality Systems

The company advances precision CNC machining for medical device components with ISO 13485–aligned quality control and ...
Medical Device and Diagnostic Industry (MD+DI)

Understanding FDA's QMSR and Cybersecurity Mandates for Medical Devices

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...
YouTube on MSN

The end of checkbox compliance: Aldo Vidinha on the FDA's quality revolution

Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...
The National Law Review

FDA Final Rule Harmonizes Medical Device Quality System Regulation with International Standard

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 ...
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 ...

Top Operating Lamp Manufacturers Driving Innovation in Medical Equipment

JINING CITY, SHANDONG PROVINCE, CHINA, February 6, 2026 /EINPresswire.com/ -- The operating lamp manufacturing sector ...
Nasdaq

Tivic Announces Successful Recertification of ISO 13485 Quality Management System and the European Medical Device CE-Mark

SAN FRANCISCO--(BUSINESS WIRE)-- Tivic Health® Systems, Inc. (“Tivic”) (Nasdaq: TIVC), a commercial-phase health technology company that develops and commercializes bioelectronic medicine, today ...

Chinese Top 3 Electric Hydraulic Operating Table Manufacturers in 2026:Leading Innovation in Medical Surgical Technology

Revolutionizing Operating Room Efficiency and Patient Care with Cutting-Edge Electric Hydraulic Technology CALIFORNIA, ...
MD&M East

Integrating Quality and the Product Life Cycle into a Single System

According to FDA, medical devices are distinguished from other discretely manufactured products because devices are “intended to affect the structure or any function of the body of man.” 1 By contrast ...

European Medical Devices Regulatory Affairs Handbook 2026: Country-Specific Regulatory Systems, ISO Standards, Clinical Trial Requirements, and Application Documentation Frameworks

Key opportunities in the European medical devices market include leveraging comprehensive regulatory guides to streamline product registration across diverse countries, utilizing soft skills for ...