Blogs
Here we provide you with key information related to the Medical Device and In Vitro Diagnostic (IVD) industry through Patient Guard’s blogs. We provide invaluable content that delves into the regulation and Quality Assurance of Medical Device and IVDs, with focus on navigating the regulatory landscapes of the United Kingdom (UK), the European Union (EU), and the United States (US).
At Patient Guard, we are not just a source of information; we are your ultimate partner in understanding and maneuvering through the complexities of Medical Device and IVD regulatory requirements, as well as Quality Assurance. Our blogs serve as a beacon, illuminating the latest updates and insights crucial for professionals and organizations operating in these highly regulated sectors.
Patient Guard is not just a repository of information; we are your ally in navigating the ever-evolving landscape of Medical Device and IVD regulations. Join us on this educational journey, where compliance meets excellence.
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Welcome to our March 2025 news letter, here we share the latest medical device regulatory news from the EU, UK and the USA as well as updated or new medical device standards that have been issued....
In today’s rapidly evolving digital health landscape, the Internet of Medical Things (IoMT) is transforming the way patients and healthcare providers interact. From smartwatches tracking heart rates to advanced devices monitoring blood glucose levels, IoMT is bridging the gap between patients and their medical teams through seamless connectivity and real-time data analytics....
In the medical device industry, packaging serves a crucial role. It not only ensures the integrity and sterility of the device but also safeguards it from environmental factors during transportation and storage. Packaging validation is, therefore, a vital process that ensures medical devices arrive in the hands of healthcare providers and patients in the safest and most effective condition....
Ensuring the safety, integrity, and effectiveness of medical devices requires strict control over their storage, handling, and transport. Medical devices are sensitive to environmental conditions such as temperature, humidity, and mechanical stress, which can compromise their functionality and sterility. Compliance with international regulatory standards, including ISO 13485, ISO 14971, EU MDR, and FDA guidelines, is essential to mitigate risks associated with storage and distribution. Through proper validation of these processes, manufacturers and suppliers can prevent product degradation, avoid regulatory penalties, and ensure patient safety. This blog explores the importance of storage, handling, and transport validation, key regulatory requirements, and best practices for ensuring compliance....
Welcome to our February 2025 news letter, here we share the latest medical device regulatory news from the EU, UK and the USA as well as updated or new medical device standards that have been issued....
Cleaning validation is a critical process for ensuring the safety and effectiveness of medical devices by verifying that they are free from harmful contaminants such as biological residues, chemical remnants, and particulate matter. This process is essential for meeting stringent regulatory standards, including ISO 13485, ISO 14971, EU MDR, and FDA guidelines, which mandate thorough cleaning protocols to mitigate risks to patients and device functionality. By defining acceptance criteria, conducting risk assessments, and performing robust validation testing, manufacturers can establish consistent cleaning processes that meet compliance requirements. ...
