Nick Recht

IQ OQ PQ and Its Role in Labeling System Validation

By Nick Recht
Nick Recht

Software validation is a critical tool used to assure the quality of device software and software automated operations, including labeling. Software validation can increase the usability and reliability of the device and label, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.

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Philip Remedios 2023

Navigating the New Normal: Achieving R&D Success in Hybrid Work Environments

By Philip Remedios, Renée Bailey
Philip Remedios 2023

Implementing a hybrid work environment with R&D teams yields significant benefits but also presents challenges. In this article, we explore how to achieve successful R&D programs within the context of hybrid environments and share key strategies and best practices to effectively navigate the challenges, including the safeguarding of sensitive information and data.

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Karim Aly

Breath-based Analysis: Revolutionizing Disease Screening for a Healthier Tomorrow

By Karim Aly
Karim Aly

Traditional screening tests suffer from a range of challenges. From logistical barriers to concerns regarding accuracy and reliability, achieving accurate diagnosis is frequently arduous. Imagine a revolutionary approach where early disease screening becomes as simple as collecting a breath sample. Thanks to cutting-edge sensor technology and advanced artificial intelligence, this vision is now on the brink of realization.

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Thomas Ring

Designing Compliant Wireless Medical Devices

By Thomas Ring
Thomas Ring

Medical Electronic Products of the future will be largely free from wires and cables, aside from a power source. “Wireless medical devices” offer numerous advantages. However, they are also subject to extensive legal regulations governing aspects such as the radio technology used in them. In addition, they may have to be assessed by a Notified Body such as TÜV SÜD.

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