The first thing one needs when working with quality management, as with numerous other areas within and outside the medical device industry, is their own copy of the standard. ISO 13485:2016 is the Medical devices – Quality management systems standard and it…
The IEC 62304 standard includes requirements for managing the life cycle of medical device software, from design and development to manufacturing, distribution, and post-market surveillance. This illustrated guide was written by Wasif Ali Syed, This guide will: What is medical…
In the world of modern medicine and healthcare, software plays an integral role in the functionality, monitoring, and management of medical devices. These software components can range from simple interfaces to complex algorithms that drive critical medical decisions. Ensuring the…
Managing informed consent and other types of consent is a vital component of clinical studies, ensuring compliance with regulations, protecting participant rights, and facilitating clear communication. However, traditional consent processes are time-consuming, cumbersome, and difficult to scale. With the 2024.2…
Compliance with industry regulations and standards is a fundamental part of Medtech. Without proper medical device compliance, companies risk harming patients, litigation, and reputational damage. Fortunately, compliance with medical device regulations and standards is not an impossible task. A company-wide…
Not all organizations recognize the importance of corporate social responsibility. Factors like industry, geographic location, and government regulation can influence a company’s motivation to “do the right thing.” To address this, the International Organization for Standardization introduced the ISO 26000 standard to help steer…
One impactful way for companies to reduce their carbon footprint is by converting their office/ factory energy consumption from conventional to renewable sources, to adopt sustainable practices. Transitioning to renewable energy can be a powerful step, offering both environmental and…
Handling Out of Specification (OOS) results effectively is a challenge. Despite rigorous processes and controls, OOS results can and do occur. Understanding what they are, why they matter, and how to manage them is essential for maintaining compliance and ensuring…
“Officer, I was only taking a look at this company’s network security posture. I wasn’t stealing or breaking stuff. So how can I be guilty of anything?” This might sound like a reasonable defense. Trouble is, the law doesn’t always…
A progressive approach to quality management system is represented by the changes, which integrate environmental sustainability into organizational procedures. These improvements allow organizations to contribute to a more sustainable future by actively combating climate change and upholding high standards of…
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