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スマートリングのŌURAは、同社の品質管理システムが医療機器の品質マネジメントシステム規格「ISO 13485」の認証を取得したと発表した。
Omniseal Solutions' Kontich site has received ISO 19443 certification for ITNS activities, which includes the design and manufacture of seals, bearings, wear components and custom...
As devices become more advanced, manufacturers often need quality control processes that are well documented, repeatable, and aligned with their internal quality systems.
A new FDA inspection standard is making Unique Device Identification marking accuracy an actively enforced requirement, and Laser Marking Technologies, LLC offers cost-conscious la...
1factory provides a unified, cloud-based platform for quality management, manufacturing quality control, incoming inspection, and supplier quality. Hundreds of manufacturers across...
To be fair, "we have a QMS" is the easiest checkbox in a notified‑body audit. The hard part is that regulators, auditors and — most importantly — frontline engineers do not care ab...
The EU AI Act deadlines for medical device AI have moved, but the compliance work has not. For companies already operating an ISO 13485 quality management system, the path to AI Ac...
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