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 ...
BOSTON--(BUSINESS WIRE)--908 Devices, a pioneer of purpose-built analytical devices for chemical analysis, today announced that it has achieved the ISO 9001:2015 certification. This latest edition of ...
Over the last 15 years, ISO 10993-18 has become a notable resource for professionals at each stage in the supply chain and manufacturing of medical devices, assisting them in the evaluation of ...
BURLINGTON, ONTARIO--(Marketwired - Nov 25, 2014) - Etratech Inc., a global leader in the design, development and manufacture of advanced electronic controls and control systems for major ...
South African Health Products Regulatory Agency (Sahpra) has indicated that ISO 13485 certification is a prerequisite for the application or renewal of a medical-device license, with effect from 1 ...
GRAND RAPIDS, MI -- A Grand Rapids medical device manufacturer now has the capability to entirely manufacture its products, leading to a new sector for the company. Rose Technologies, 1440 Front Ave.
WALTHAM, Mass.--(BUSINESS WIRE)-- ModusLinkGlobal Solutions ™ Inc. (NAS: MLNK) is announcing its Solution Centers in Raleigh, North Carolina and Brno, Czech Republic have achieved ISO 13485-based ...
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