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Mastering Medical Device Standards: The Essential Guide for All Device Types
Welcome to our comprehensive guide on mastering medical device standards! In this video, we delve into the essential standards that ensure safety, quality, and effectiveness for all medical device types. Whether you're a manufacturer, healthcare professional, or simply interested in the regulatory landscape, this video is for you.
**In this video, we will cover:**
1. **ISO 14971:** Risk management and its crucial role in minimizing potential hazards throughout the lifecycle of a medical device.
2. **ISO 13485:** Quality management systems and how they are designed to meet regulatory requirements for the medical device industry.
3. **ISO 15223-1:** Medical device labeling and symbols, ensuring clear communication and compliance with international requirements.
4. **ISO 62366-1:** Usability engineering to optimize the design and functionality of medical devices for better user experience and safety.
Join us as we break down these complex standards into easy-to-understand segments, providing you with the knowledge to navigate and implement these critical guidelines effectively. Don't forget to like, subscribe, and hit the notification bell for more insightful content on medical device regulations and standards!
#MedicalDeviceStandards #ISO14971 #ISO13485 #ISO15223-1 #ISO62366-1 #MedicalDeviceRegulations #QualityManagement #RiskManagement #UsabilityEngineering
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Відео

Wearable Medical Devices Transforming Healthcare
Переглядів 34Місяць тому
As Medical Device Wearable Technology becomes more prominent and more advanced, it is essential that tech companies developing wearable technology ensure they have their compliance requirements met. Patient Guard is an established medical device regulatory consultancy with expertise in this area. It is important that you partner with experts in this area who are able to guide you through the co...
ISO 14971 and the risk management of medical devices
Переглядів 2182 місяці тому
ISO 14971 and the Risk Management of Medical Devices plays an integral part of demonstrating product safety throughout the life cycle of medical devices. In fact, the focus of all global medical device regulations relate to risk and how these are mitigated, to demonstrate that the clinical benefit of using the medical device outweighs the risks associated with using the medical device. ISO 1497...
IEC 62366 1 Usability Engineering for Medical Devices
Переглядів 1233 місяці тому
IEC 62366-1 is a standard related to usability engineering for medical devices. It provides guidance on how to apply human factors engineering to the design and evaluation of medical devices to ensure their usability and safety. Here's an overview of the key points covered in IEC 62366-1: 1. Scope : The standard applies to the process of designing, evaluating, and improving the usability of med...
The sterilisation of medical devices and the methods used
Переглядів 1873 місяці тому
Sterilization of medical devices is a critical process aimed at eliminating or destroying all forms of microbial life, including bacteria, viruses, fungi, and spores, from the surface or material of the device. This is essential to prevent infection and ensure the safety of patients undergoing medical procedures. There are several methods commonly used for sterilizing medical devices: 1. Steam ...
Medical Device Labelling - ISO 15223 Medical Symbols
Переглядів 1253 місяці тому
Medical device labeling is a critical aspect of ensuring patient safety, regulatory compliance, and effective communication between healthcare professionals, patients, and manufacturers. Proper labeling provides essential information about the device, including its intended use, instructions for use, potential risks, and other important details. One standard widely used in medical device labeli...
The Electrical Safety of Medical Devices
Переглядів 1623 місяці тому
Medical device electrical safety is paramount in the healthcare industry, ensuring the protection of patients, healthcare professionals, and the general public from potential hazards associated with electrical devices used in medical settings. From diagnostic equipment to life-saving devices, electrical safety standards are rigorously enforced to minimize risks and ensure optimal performance. H...
Clinical Evaluation of Medical Devices
Переглядів 5044 місяці тому
To demonstrate that medical devices are safe, and their performance is ‘state of the art’ in line with their clinical intended use, medical device manufacturers must perform clinical evaluation. Clinical evaluation is a requirement of the Medical Device Regulation 2027/745 in the European Union and the UK medical device regulations 2002 in the United Kingdom. Clinical Evaluation forms part of t...
Regulating AI (Artificial Intelligence) Medical Devices
Переглядів 594 місяці тому
We are on the cusp of a medical revolution, as important as (or perhaps even more than) the discovery of penicillin. With the advancement of Artificial Intelligence (AI) systems and the exponential increase in chip processing power, AI, has the power to revolutionise healthcare. AI is already being used in many healthcare medical devices, Diabetic Retinopathy Screening being just one. The syste...
Identifying if a product is an IVD under EU IVDR 2017/746
Переглядів 294 місяці тому
Are you grappling with the complexities of the In Vitro Diagnostic Regulation (IVDR) 2017/746? Identifying whether your product qualifies as an in vitro diagnostic (IVD) device under this regulation is crucial for compliance in the European market. In this insightful video, we unravel the intricacies of IVDR 2017/746 and provide practical guidance on how to ascertain if your product falls withi...
Navigating EU Regulations: Is My Product a Medical Device?
Переглядів 454 місяці тому
Are you uncertain about whether your product falls under the classification of a medical device in the European Union? Understanding the regulatory landscape can be daunting, but fear not - our comprehensive guide is here to help! In this enlightening UA-cam video, we delve into the intricate world of EU regulations to answer the burning question: Is my product considered a medical device? Whet...
FDA Medical Device Classification
Переглядів 2145 місяців тому
Welcome to our channel! In this video, we delve into the world of FDA classification of medical devices. Whether you're a healthcare professional, medical device developer, or simply curious about regulatory standards, this guide will provide valuable insights. The Food and Drug Administration (FDA) plays a pivotal role in ensuring the safety and efficacy of medical devices available in the mar...
Classification of Medical Devices - EU 2017/745
Переглядів 5315 місяців тому
🔍 Dive into the intricate world of medical device classification under the European Medical Device Regulation (MDR) 2017/745 🏥 In this video, we break down the key aspects of MDR 2017/745, providing a clear and concise overview of the classification process for medical devices. Whether you're a healthcare professional, regulatory affairs specialist, or simply curious about the intricate regulat...
A History of Medical Device Regulation - FDA
Переглядів 1005 місяців тому
🏥 Uncover the fascinating journey of medical device regulation in the United States with our latest video, From humble beginnings to the sophisticated regulatory landscape we know today, join us on a chronological exploration of the pivotal milestones, regulatory frameworks, and key turning points that have shaped the oversight of medical devices. 🔍 Delve into the early 20th century, where the ...
A History of Medical Devices from ancient times to the present day
Переглядів 1815 місяців тому
🕰️ Step into the riveting journey of medical innovation with our latest video, " A History of Medical Devices." 🌐 Join us as we unravel the remarkable timeline of medical advancements that have revolutionized healthcare throughout the ages! 👩‍⚕️ From ancient healing tools to cutting-edge technology, this documentary-style exploration delves deep into the origins of medical devices that have pla...
Exploring Medical Device UDI (Unique Device Identification)
Переглядів 1135 місяців тому
Exploring Medical Device UDI (Unique Device Identification)
Medical Devices - An Introduction to the EU EUDAMED system
Переглядів 2436 місяців тому
Medical Devices - An Introduction to the EU EUDAMED system
Software as a Medical Device (SaMD) and how it is regulated in the EU
Переглядів 2506 місяців тому
Software as a Medical Device (SaMD) and how it is regulated in the EU
Understanding Medical Device Biological Evaluation - Biological Evaluation Report ISO 10993-1
Переглядів 1757 місяців тому
Understanding Medical Device Biological Evaluation - Biological Evaluation Report ISO 10993-1
Biological Evaluation Plan (BEP) - Medical Devices (ISO 10993)
Переглядів 707 місяців тому
Biological Evaluation Plan (BEP) - Medical Devices (ISO 10993)
The Biological Evaluation of Medical Devices
Переглядів 1437 місяців тому
The Biological Evaluation of Medical Devices
EU Authorised Representative Role - Medical Devices
Переглядів 417 місяців тому
EU Authorised Representative Role - Medical Devices
Medical Devices - UK Responsible Person Role
Переглядів 1018 місяців тому
Medical Devices - UK Responsible Person Role
The UK vs the EU Medical Device Regulations - What are the key differences?
Переглядів 2488 місяців тому
The UK vs the EU Medical Device Regulations - What are the key differences?
Understanding PRRC (Person Responsible for Regulatory Compliance) under EU MDR & IVDR Regulations
Переглядів 798 місяців тому
Understanding PRRC (Person Responsible for Regulatory Compliance) under EU MDR & IVDR Regulations
Understanding the FDA Medical Device 510k Process
Переглядів 5968 місяців тому
Understanding the FDA Medical Device 510k Process
Patient Guard Introduction Video
Переглядів 388 місяців тому
Patient Guard Introduction Video
Medical Device UKCA marking
Переглядів 918 місяців тому
Medical Device UKCA marking
CE Marking for Medical Devices: Ensuring Safety and Compliance
Переглядів 2309 місяців тому
CE Marking for Medical Devices: Ensuring Safety and Compliance
In Vitro Diagnostic Regulations EU 2017/746 - What are they?
Переглядів 2329 місяців тому
In Vitro Diagnostic Regulations EU 2017/746 - What are they?

КОМЕНТАРІ

  • @taytay6563
    @taytay6563 6 місяців тому

    Thank you for the concise explanation!

  • @dr._Shubs
    @dr._Shubs 9 місяців тому

    is this AI or human?

  • @darrellbruh1335
    @darrellbruh1335 9 місяців тому

    what's with the creepy fake woman tho

  • @stevetrosok9438
    @stevetrosok9438 9 місяців тому

    Is she AI generated CGI?