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.
Categories
Great news everyone! Patient Guard is thrilled to bring you fresh updates
through our May 2024 newsletter. We’re super excited to share that
we’ve started offering Training courses – kicking off with our inaugural course on ‘EU Medical Device Regulations 2017/745’....
As we step into the spring of 2024, we are delighted to present the latest edition of Patient Guard’s Newsletter, dedicated to providing you with insightful updates and invaluable resources in medical device and In Vitro Diagnostics (IVD) regulatory affairs and quality assurance consultancy.
We have been busy updating our website to change it from a generic consultancy website to an informative resource for medical device and IVD information....
In medical device design, the efficacy, safety, and user experience is paramount. While the technical function of a device is unquestionably significant, its usability can often determine its real-world impact. This is where standards like IEC 62366-1 come into play, offering a structured approach to integrating user-centred design principles into the development process. In this blog, we'll delve deeper into the significance of IEC 62366-1, its underlying principles, practical implementation strategies, and the broader implications for medical device innovation and patient care....
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. ...
March already! It's starting to look like spring, the daffodils are out, it's staying light for longer.
This month we exhibited at the Medical Technology Exhibition at the Coventry Arena, here is our CEO and Founder David Small at our Stand. It was lovely to meet many of our current customers and lots of potential new ones too.
This month we have also been updating our website and our marketing content. To keep UpToDate with the latest regulatory news and content from Patient Guard subscribe to our news letter. You will receive a news letter email with the latest news at the beginning of the month, which is usually 2 to 3 weeks earlier than you will get it on our website news letter. ...
In the fast-paced world of medical device manufacturing, regulatory standards are the bedrock of patient safety and product quality. Recently, the European Union has taken a significant step by extending Article 120 of the EU Regulation 2017/745 and EU Regulation 2017/746. This move has been made to address the mounting backlog of CE mark certifications and re-certifications within notified bodies, the entities responsible for ensuring that medical devices meet stringent quality and safety requirements before they reach the market. In this blog post, we'll delve into the implications of this extension for medical device manufacturers and emphasize the critical importance of continued compliance....
