Blogs from Patient Guard
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.
To elevate your understanding and empower your knowledge, Patient Guard offers complimentary consultations. Reach out to us today, and discover how our expertise can assist you in achieving compliance for your medical devices and IVD products. Our team is dedicated to providing personalized guidance tailored to your specific needs, ensuring a seamless journey toward regulatory adherence.
In addition to our enlightening blog content, we invite you to explore our enriching YouTube channel and LinkedIn page. Here, industry updates and valuable insights come to life through engaging multimedia formats. Furthermore, our sister website, QMSREGS.com, stands as a comprehensive resource, offering a diverse range of training courses and Medical Device and IVD templates. This integrated approach ensures that your regulatory needs are not only met but exceeded.
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.
The Future of Healing: How AI is Revolutionizing the Medical Device Industry
In the realm of healthcare, artificial intelligence (AI) is not just a buzzword; it’s a transformative force that is reshaping the landscape of medicine and medical technology. Over the past decade, we have witnessed remarkable advancements in AI, and its impact on the medical device industry is nothing short of revolutionary. As we step into the next five years, the synergy between AI and medical devices is poised to usher in a new era of healthcare innovation, efficiency, and patient outcomes.
Navigating the Future: The Growing Medical Device Industry and the Role of Regulation
In an era marked by unprecedented advancements in healthcare technology, the medical device industry stands as a beacon of innovation. The development of cutting-edge medical
EUDAMED: Enhancing Transparency and Safety in Medical Device Regulation
In today’s rapidly evolving healthcare landscape, ensuring the safety and effectiveness of medical devices is of paramount importance. To address this, the European Union (EU)
Quality Assurance & Quality Control
Quality assurance (QA) and quality control (QC) are two important concepts in the medical device industry. Although they are related, there are distinct differences between the two. In this blog post, we will explore the difference between medical device quality assurance and quality control.
Medical Device Start-up – is not applying a regulatory strategy early on costing more in the long run?
Starting a medical device company can be a stressful time, what with design and development activities, finding funding, ensuring you don’t run out of capital etc.
One very important area that is often not considered early enough is the regulatory side. Many medical device startup companies think that the regulatory activities don’t begin until the device has been developed and they often don’t realise the cost involved in ensuring that the medical device meets the safety requirements of the medical device regulations globally
What is the importance of medical device registration?
Medical devices are essential pieces of equipment, and there are a lot of them out there on the market. In this blog, we’re looking at
Regulating medical devices in the UK
Ensuring the safety of medical devices before they enter the market is very important. There are various regulations that must be followed based on the
Person Responsible for Regulatory Compliance (PRRC) MDR
Part of these new measures is the introduction of a Person Responsible for Regulatory Compliance (PRRC). Article 15 of regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR), the legal requirements for the PRRC are presented.
They state that each manufacturer and authorised representative (if applicable) must have at their disposal a PRRC, who has the necessary requisite qualifications and experience for regulatory compliance.
ISO 13485 Requirements Quality Management System
ISO 13485 requirements guide for: Medical Devices – Quality Management Systems – Requirements for regulatory purposes Introduction ISO 13485 can be used by organisations that
Medical Device Classification EU
In the EU Medical Devices are categorised into 6 classes, these are Class I, Class Is (sterile), Class Im (measuring), Class IIa, Class IIb and Class III.
Class I devices are considered to be of low risk, Class II devices as medium risk and Class III devices as high risk.
Depending on the classification of device determines the regulatory conformity pathway that needs to be taken to gain compliance and allow manufacturers to place product on the EU market.
Medical Devices Classification UK
In the UK Medical Devices are categorised into 6 classes, these are Class I, Class Is (sterile), Class Im (measuring), Class IIa, Class IIb and Class III.
Class I devices are considered to be of low risk, Class II devices as medium risk and Class III devices as high risk.
Depending on the classification of device determines the regulatory conformity pathway that needs to be taken to gain compliance and allow manufacturers to place product on the UK market.
Quality Assurance vs Quality Control
Quality Assurance (QA) vs Quality Control (QC) is a commonly asked question but both are important aspects of Quality Management Systems (QMS). They work side
Top 5 quality management system failures
In this blog, we will discuss some of the (in our opinion) top 5 quality management system-related failures. These failures had massive consequences, including loss
IVD Directive Essential Requirements Checklist
The 8 Step Essential Requirement checklist for IVD Directive. The IVDR EU 2017/746 is responsible for governing the regulatory market access for in vitro diagnostic
A guide to ISO 13485
Implementing quality management system (QMS) iso 13485 couldn’t be easier with our step by step guide. A quality management system is necessary in medical compliance.
The Benefits of ISO 9001 Quality Management System
The quality management system ISO 9001 is a set of international standards to ensure efficiency and productivity in an organisation. It is known as the