Patient Guard Limited
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Medical Device Sterilization: Ensuring Patient Safety and Compliance
Medical Device Sterilization: Ensuring Patient Safety and Compliance
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.
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Переглядів: 31

Відео

Software as a Medical Device (SaMD): Navigating the Regulatory Landscape2:53Software as a Medical Device (SaMD): Navigating the Regulatory Landscape
Software as a Medical Device (SaMD): Navigating the Regulatory Landscape
Переглядів 30День тому
Software as a Medical Device (SaMD): Navigating the Regulatory Landscape Software as a Medical Device (SaMD) has revolutionised the healthcare industry. From software being incorporated into hardware such as infusion pumps to software being a standalone medical device, such as in apps. Understanding how SaMD is regulated is critical to its success when being launched as a product. Click here fo...
Medical Device Design and Development5:02Medical Device Design and Development
Medical Device Design and Development
Переглядів 3414 днів тому
Medical Device Design and Development Planning for the design and development of a medical device is a requirement of regulatory systems. All manufacturers of Medical Devices are required to maintain a Quality Management System, in the USA this is determined under the CFR Title 21 part 820. Within the European Union, it is placed within demonstrating certificated compliance with international s...
Post Market Clinical Follow-up PMCF | Patient Guard4:59Post Market Clinical Follow-up PMCF | Patient Guard
Post Market Clinical Follow-up PMCF | Patient Guard
Переглядів 3621 день тому
Post Market Clinical Follow-up of medical devices is an important part of Post Market Surveillance. It is the process of monitoring devices in the real world environment. Post-market clinical follow-up (PMCF) plays a crucial role in ensuring the ongoing safety, performance, and compliance of medical devices after they have been placed on the market. This process involves monitoring, collecting ...
Medical Device Post Market Surveillance | Patient Guard5:05Medical Device Post Market Surveillance | Patient Guard
Medical Device Post Market Surveillance | Patient Guard
Переглядів 38Місяць тому
Post-market surveillance (PMS) is essential to maintaining the safety, performance, and reliability of medical devices after they reach the market. In this video, we explore the critical role PMS plays in upholding compliance and fostering innovation across the EU, UK, and USA. Discover how distinct regulatory frameworks, including the EU MDR, UK MHRA guidelines, and FDA regulations, guide PMS ...
Medical Device Clinical Evaluation | Patient Guard5:06Medical Device Clinical Evaluation | Patient Guard
Medical Device Clinical Evaluation | Patient Guard
Переглядів 41Місяць тому
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 medica...
Risk Management of Medical Devices and IVDs | Patient Guard4:40Risk Management of Medical Devices and IVDs | Patient Guard
Risk Management of Medical Devices and IVDs | Patient Guard
Переглядів 53Місяць тому
We’re diving into a critical aspect of medical device and IVD (in vitro diagnostic) regulations-risk management. For manufacturers, effectively managing risks throughout the entire lifecycle of your devices is not just a regulatory requirement-it’s a cornerstone of patient safety and product success. Exploring ISO 14971, the globally recognized standard for medical device risk management, and h...
Medical Device and IVD Technical Files | Patient Guard4:35Medical Device and IVD Technical Files | Patient Guard
Medical Device and IVD Technical Files | Patient Guard
Переглядів 442 місяці тому
A medical device technical file is a concise set of documents created by a manufacturer to explain the performance and safety of a particular Medical Device in a clear, well-organized, easily searchable, and unambiguous manner. In order to prove compliance with the general safety and performance criteria of the legislation, the manufacturer must have - and keep up-to-date - this technical docum...
Understanding the Role of the PRRC for Medical Devices and IVDs in the EU | Patient Guard5:29Understanding the Role of the PRRC for Medical Devices and IVDs in the EU | Patient Guard
Understanding the Role of the PRRC for Medical Devices and IVDs in the EU | Patient Guard
Переглядів 422 місяці тому
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 ...
EU Authorised Representative PPE | Patient Guard4:12EU Authorised Representative PPE | Patient Guard
EU Authorised Representative PPE | Patient Guard
Переглядів 82 місяці тому
Understanding Personal Protective Equipment (PPE) Regulations in the EU is essential for ensuring the safety, quality, and compliance of PPE products. In this video, Patient Guard breaks down the key regulations governing PPE in the European Union, highlighting how these standards safeguard workers and the public from hazards. Learn about the conformity requirements, certification processes, an...
EU Representative for Cosmetics | Patient Guard3:52EU Representative for Cosmetics | Patient Guard
EU Representative for Cosmetics | Patient Guard
Переглядів 92 місяці тому
Cosmetics regulations play a crucial role in ensuring the safety, quality, and effectiveness of the products we use on our skin, hair, and body. These regulations help protect consumers by preventing harmful ingredients, reducing health risks, and promoting accurate labeling and product claims. Stay informed about how these guidelines safeguard your wellbeing! EU Representative. #CosmeticSafety...
EU Authorised Representative | Patient Guard6:07EU Authorised Representative | Patient Guard
EU Authorised Representative | Patient Guard
Переглядів 352 місяці тому
EU Authorised Representative 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 A...
Personal Protective Equipment (PPE) Regulations | Patient Guard5:08Personal Protective Equipment (PPE) Regulations | Patient Guard
Personal Protective Equipment (PPE) Regulations | Patient Guard
Переглядів 373 місяці тому
In this informative video from Patient Guard, we dive deep into the essential regulations surrounding Personal Protective Equipment (PPE). Discover how these regulations are designed to ensure the safety, quality, and efficacy of PPE, protecting individuals from various hazards in the workplace and beyond. - What PPE regulations are and why they matter - Key standards that govern PPE safety and...
UKRP for Cosmetics | Patient guard3:43UKRP for Cosmetics | Patient guard
UKRP for Cosmetics | Patient guard
Переглядів 123 місяці тому
UK Rep Cosmetics, we dive into the critical role of cosmetics regulations in the UK. Discover how these guidelines are designed to protect consumers by ensuring the safety, quality, and efficacy of products used on the skin, hair, and body. We’ll explore the importance of preventing harmful ingredients, safeguarding against health risks, and ensuring that all products are accurately labeled wit...
UK Responsible Person (UKRP) - Medical Devices | Patient Guard4:33UK Responsible Person (UKRP) - Medical Devices | Patient Guard
UK Responsible Person (UKRP) - Medical Devices | Patient Guard
Переглядів 323 місяці тому
The UKRP must provide written evidence that they have the manufacturer’s authority to act as their UK Responsible Person. Importers and distributors are not required to appoint a UK Responsible Person. The UKRP acts on behalf of the non-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. As noted above, this includes registering the manufacturer’s devices...
The Biological Evaluation of Medical Devices | Patient Guard2:22The Biological Evaluation of Medical Devices | Patient Guard
The Biological Evaluation of Medical Devices | Patient Guard
Переглядів 743 місяці тому
The Biological Evaluation of Medical Devices | Patient Guard
Understanding Cytotoxicity Testing | Patient Guard3:24Understanding Cytotoxicity Testing | Patient Guard
Understanding Cytotoxicity Testing | Patient Guard
Переглядів 764 місяці тому
Understanding Cytotoxicity Testing | Patient Guard
In Vitro Skin Irritation Testing: ISO 10993-23 Standard | Patient Guard4:10In Vitro Skin Irritation Testing: ISO 10993-23 Standard | Patient Guard
In Vitro Skin Irritation Testing: ISO 10993-23 Standard | Patient Guard
Переглядів 534 місяці тому
In Vitro Skin Irritation Testing: ISO 10993-23 Standard | Patient Guard
Drug Stability in Medical Devices | Patient Guard4:03Drug Stability in Medical Devices | Patient Guard
Drug Stability in Medical Devices | Patient Guard
Переглядів 424 місяці тому
Drug Stability in Medical Devices | Patient Guard
Extractables and Leachables Testing for Medical Devices in ISO 10993 | Patient Guard7:43Extractables and Leachables Testing for Medical Devices in ISO 10993 | Patient Guard
Extractables and Leachables Testing for Medical Devices in ISO 10993 | Patient Guard
Переглядів 1324 місяці тому
Extractables and Leachables Testing for Medical Devices in ISO 10993 | Patient Guard
Understanding the core elements of Quality Management Systems | Patient Guard5:18Understanding the core elements of Quality Management Systems | Patient Guard
Understanding the core elements of Quality Management Systems | Patient Guard
Переглядів 1544 місяці тому
Understanding the core elements of Quality Management Systems | Patient Guard
5 Differences Between ISO 13485 & FDAs Medical Device QSR | | Patient Guard4:215 Differences Between ISO 13485 & FDAs Medical Device QSR | | Patient Guard
5 Differences Between ISO 13485 & FDAs Medical Device QSR | | Patient Guard
Переглядів 1935 місяців тому
5 Differences Between ISO 13485 & FDAs Medical Device QSR | | Patient Guard
Mastering Medical Device Standards: The Essential Guide for All Device Types8:01Mastering Medical Device Standards: The Essential Guide for All Device Types
Mastering Medical Device Standards: The Essential Guide for All Device Types
Переглядів 2317 місяців тому
Mastering Medical Device Standards: The Essential Guide for All Device Types
Wearable Medical Devices Transforming Healthcare1:40Wearable Medical Devices Transforming Healthcare
Wearable Medical Devices Transforming Healthcare
Переглядів 597 місяців тому
Wearable Medical Devices Transforming Healthcare
ISO 14971 and the risk management of medical devices7:19ISO 14971 and the risk management of medical devices
ISO 14971 and the risk management of medical devices
Переглядів 6298 місяців тому
ISO 14971 and the risk management of medical devices
IEC 62366 1 Usability Engineering for Medical Devices2:47IEC 62366 1 Usability Engineering for Medical Devices
IEC 62366 1 Usability Engineering for Medical Devices
Переглядів 4469 місяців тому
IEC 62366 1 Usability Engineering for Medical Devices
The sterilisation of medical devices and the methods used3:36The sterilisation of medical devices and the methods used
The sterilisation of medical devices and the methods used
Переглядів 7049 місяців тому
The sterilisation of medical devices and the methods used
Medical Device Labelling - ISO 15223 Medical Symbols3:35Medical Device Labelling - ISO 15223 Medical Symbols
Medical Device Labelling - ISO 15223 Medical Symbols
Переглядів 3099 місяців тому
Medical Device Labelling - ISO 15223 Medical Symbols
The Electrical Safety of Medical Devices4:23The Electrical Safety of Medical Devices
The Electrical Safety of Medical Devices
Переглядів 5099 місяців тому
The Electrical Safety of Medical Devices
Clinical Evaluation of Medical Devices4:44Clinical Evaluation of Medical Devices
Clinical Evaluation of Medical Devices
Переглядів 66510 місяців тому
Clinical Evaluation of Medical Devices

КОМЕНТАРІ

  • @Garuda341
    @Garuda341 2 місяці тому

    ❤

  • @zul.cenaheyn
    @zul.cenaheyn 4 місяці тому

    Is 510k documents needed for ultrasonic dental tartar removal machine?

    • @patientguardlimited6362
      @patientguardlimited6362 4 місяці тому

      It depends, you would need to check the FDA Medical Device Classification database to see if there is an equivalent product already on the US market. If there is, it will tell you if the product is 510k exempt or if a 510k submission is required. If there are no equivalent products on the US market then you may need to submit a PMA or request FDA guidance on classification.

    • @zul.cenaheyn
      @zul.cenaheyn 4 місяці тому

      @@patientguardlimited6362 thank you :)

  • @nkqualitytrainer1208
    @nkqualitytrainer1208 5 місяців тому

    So nice information sir

  • @taytay6563
    @taytay6563 Рік тому

    Thank you for the concise explanation!

  • @dr._Shubs
    @dr._Shubs Рік тому

    is this AI or human?

  • @darrellbruh1335
    @darrellbruh1335 Рік тому

    what's with the creepy fake woman tho

  • @stevetrosok9438
    @stevetrosok9438 Рік тому

    Is she AI generated CGI?