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.
Categories
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. ...
Medical Device labelling is a key requirement of regulations world wide. Manufacturers of medical devices are required to ensure that the products they place on the market are appropriately labelled, this enables traceability, and key information to users on how to use the devices safely. ...
Notified Bodies are essential for ensuring product safety and compliance. Whether your business operates in the European Union (EU) or the United Kingdom (UK), understanding how to work with these organizations is vital. This blog explains the role of Notified Bodies, their importance under EU and UK regulations, and what manufacturers need to know....
The General Safety and Performance Requirements (GSPRs) are detailed in the EU Medical Device Regulations (MDR) EU 2017/745 and detail what a manufacturer must show to prove that the medical devices they sell are safe and perform as intended. ...
Electrical safety in medical devices is important to ensure that users of electronic medical device equipment are not subject to electrical risks. Medical Device manufacturers must ensure that their electronic devices are safe and that any risks are as low as possible. ...
Medical Device Sterilization is a key aspect of ensuring certain Medical Devices are safe and effective. Sterilization ensures that the medical device is free from microorganisms before they are used on patients. Reducing the risk of infections....
