Blogs
Embark on a journey of comprehensive insights and updates within the dynamic landscape of the Medical Device and In Vitro Diagnostic (IVD) industry through Patient Guard’s cutting-edge blogs. Our commitment extends to providing invaluable content that delves into the intricate realms of Medical Device Regulation and IVD Regulation, with a sharp 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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All Medical Devices that are placed on the market in the EU and the UK must undergo Clinical Evaluation. Clinical Evaluation is a review of all the data that has been generated by the medical device manufacturer; pre-clinical, clinical and post market. The review of this data is performed to assess that the benefits of using the medical device outweigh the risks associated with using the medical device within the devices clinical intended purpose. ...
ISO 14971 is the global standard for managing risks in medical devices, guiding manufacturers through identifying, evaluating, and mitigating risks throughout the product lifecycle....
Welcome to our November 2024 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....
The EU Authorised Representative role for medical devices has existing since before the introduction of the Medical Device and In Vitro Diagnostic Regulations (EU MDR 2017/745 and EU IVDR 2017/746) were introduced in 2017 and was a requirement of their predecessors the medical device directives.
Since the MDR and IVDR Regulations were introduced the role of the EU Authorised Representative has become wider in scope and responsibilities....
PPE Regulations are in place to ensure the safety, quality, and efficacy of products used to protect the body from hazards. Regulations ensure that personal protective equipment is fit for purpose and conforms to standards....
Cosmetics Regulations are in place to ensure the safety, quality, and efficacy of products used on the skin, hair, and body. Regulations prevent the inclusion of harmful ingredients, protect consumers from potential health risks, and ensure accurate labeling and claims. ...
