Medical Device Regulations & Compliance

行业观点

IVDR合规性:您可能需要重新考虑临床证据策略

欧洲通知的身体反馈表明,在临床证据中,尤其是在临床性能数据周围,发现了2017/746(IVDR)的体外诊断医疗设备法规的最大差距。本文还涵盖了欧盟和FDA要求之间重叠的讨论。

FDA Releases Guidance On Cybersecurity In Medical Devices

The digital revolution that resulted in the IoT, IoMT, SaMD, and connected devices comes with the possibility of cyberattacks. The FDA's latest efforts to enhance medical device cybersecurity include a new draft guidance (covered in this article) and bipartisan congressional support of the PATCH Act of 2022 (which will be covered in a future article).

采取ESG措施如何使我的MedTech具有竞争优势?

Amid continuing focus on environmental, social, and governance (ESG) priorities among investors across every industry, medtech companies need to begin revisiting business models and developing new sustainability strategies for competitive edge as well as regulatory compliance.

EU MDR’s Benefit-Risk Ratio: Making Your Clinical Evaluations Safety-Focused

欧盟的医疗设备调节是指多次利益风险比率,尤其是在临床评估以及附件I的第1和8节中。但是,没有普遍接受的方法来计算这种比率。本文提出了一种以专注于患者安全性以及跟踪产品安全概况变化的能力来计算它的方法。

WHITE PAPERS & CASE STUDIES

有效的培训管理如何帮助您防止质量问题

培训定义了您组织中最重要的资产的质量:您的员工。良好的培训管理过程是针对质量差的预防措施。

MedTech制188bet软件下载苹果造:从中断到进化

医疗设备制造是一个复杂的行业,188bet软件下载苹果因此确定每个公司要数字化的领域可能很困难和不同。在这里,我们探讨了医疗设备和诊断制造商正在拥抱数字工具,以最大程度地提高数据的价值,因为该行业从危机模式到进化。

Vital Signs Of The Medical Device Industry

The medical device industry emerged from 2020 a little beat up and bruised, but those that were able to adapt successfully will act as models for 2021 and beyond. As the medtech ecosystem and medical device regulations continue to evolve in conjunction with the continued pressure to meet demand while adhering to quality expectations, medical device companies must embrace digital transformation and shifts in mindset to remain competitive.

Why Automation Is Essential For Document Control Compliance

在医疗设备开发中,文档控制过程的速度,效率和准确性是重中之重。监管机构正在拥抱进步技术,以有效地实现确保公共卫生和安全的使命,包括与文档直接相关的增强。

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