The adoption of a quality management system (QMS) should be a strategic decision of a Nuclear Medicine service. Its design and implementation will be influenced by various factors, for example the ...

〜クラウド型サービスで迅速かつ柔軟なプロセス改善が可能に〜 横河電機株式会社（本社 : 東京都武蔵野市 取締役 代表執行役社長 : 奈良 寿）は、OpreX(TM)Operational Risk Managementのラインアップとして「OpreX Quality Management System」を本日発売しますのでお知らせ ...

To improve the overall safety and performance of medical devices, the United States FDA has proposed an amendment to the Code of Federal Regulations (CFR) for 21 CFR4 Part 820 of the current good ...

The purpose of the e-learning is to provide guidance to technical monitoring services in radiation safety on developing and implementing a quality management system consistent with the requirements ...

Opinions expressed by Digital Journal contributors are their own. In today’s environment, the need for a quality management system is not merely a luxury. Still, instead, it is an essential ...

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, ...

Find out how to get EQ reviewers involved early and comply with audit-quality standards. Firms will need to learn from mistakes, fine-tune systems, and adapt to new ways of thinking about quality.

How often and how much does your firm think about quality? Every auditor is, by nature, committed to quality. Every firm has final quality control steps built into its production process. However, ...