- Видео 86
- Просмотров 38 096
Patient Guard Limited
Великобритания
Добавлен 5 фев 2023
Patient Guard is a Medical Device Regulatory Affairs and Quality Assurance Service Business. We help Medical Device & In Vitro Diagnostic (IVD) Device manufacturers, distributors and other stakeholders remain compliant with the Medical Device Regulations.
Our Medical Device & IVD experts can assist with EU & UK Medica Device Regulation and Quality Assurance Requirements.
Our videos aim to be an educational tool for people wanting to learn more about Medical Devices & IVDs. As well as Medical Device Consultancy, we also sell templates to help professionals in the Medical Device sector with their compliance needs.
What ever your Medical Device compliance needs we will be happy to help.
Our Medical Device & IVD experts can assist with EU & UK Medica Device Regulation and Quality Assurance Requirements.
Our videos aim to be an educational tool for people wanting to learn more about Medical Devices & IVDs. As well as Medical Device Consultancy, we also sell templates to help professionals in the Medical Device sector with their compliance needs.
What ever your Medical Device compliance needs we will be happy to help.
Post Market Clinical Follow-up PMCF | Patient Guard
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 data, and assessing the real-world performance of medical devices to identify any potential risks or issues that may not have been apparent during pre-market clinical trials. As regulatory requirements evolve, manufacturers are required to implement robust PMCF strategies to maintain product approval...
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 data, and assessing the real-world performance of medical devices to identify any potential risks or issues that may not have been apparent during pre-market clinical trials. As regulatory requirements evolve, manufacturers are required to implement robust PMCF strategies to maintain product approval...
Просмотров: 17
Видео
Medical Device Post Market Surveillance | Patient Guard
Просмотров 27День назад
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 Guard
Просмотров 3221 день назад
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 Guard
Просмотров 49Месяц назад
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 Guard
Просмотров 42Месяц назад
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 Guard
Просмотров 41Месяц назад
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 Guard
Просмотров 7Месяц назад
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 Guard
Просмотров 9Месяц назад
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 Guard
Просмотров 352 месяца назад
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 Guard
Просмотров 332 месяца назад
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 guard
Просмотров 102 месяца назад
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 Guard
Просмотров 292 месяца назад
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 Guard
Просмотров 743 месяца назад
The Biological Evaluation of Medical Devices In healthcare, ensuring the safety and efficacy of medical devices is paramount. Patients rely on these devices for diagnosis, treatment, and improved quality of life. Biological evaluation plays a pivotal role in determining the biological safety of these devices. Governed by international standards, most notably the ISO 10993 series, biological eva...
Understanding Cytotoxicity Testing | Patient Guard
Просмотров 763 месяца назад
In the highly regulated world of medical devices, ensuring patient safety is paramount. One of the essential components of this safety assurance is cytotoxicity testing, specifically adhering to ISO 10993-5 standards. This blog explores the importance of ISO 10993-5 cytotoxicity testing, particularly for medical devices that come into direct contact with patients, and how it contributes to the ...
In Vitro Skin Irritation Testing: ISO 10993-23 Standard | Patient Guard
Просмотров 533 месяца назад
At Patient Guard, we understand the critical importance of ensuring the safety of medical devices. In this video, we focus on In Vitro Skin Irritation Testing and the ISO 10993-23 Standard. Skin irritation is a significant concern for medical devices that come into direct and prolonged contact with the skin. Without proper testing, products could cause anything from minor redness to severe derm...
Drug Stability in Medical Devices | Patient Guard
Просмотров 423 месяца назад
Drug Stability in Medical Devices | Patient Guard
Extractables and Leachables Testing for Medical Devices in ISO 10993 | Patient Guard
Просмотров 1234 месяца назад
Extractables and Leachables Testing for Medical Devices in ISO 10993 | Patient Guard
Understanding the core elements of Quality Management Systems | Patient Guard
Просмотров 1514 месяца назад
Understanding the core elements of Quality Management Systems | Patient Guard
5 Differences Between ISO 13485 & FDAs Medical Device QSR | | Patient Guard
Просмотров 1744 месяца назад
5 Differences Between ISO 13485 & FDAs Medical Device QSR | | Patient Guard
Mastering Medical Device Standards: The Essential Guide for All Device Types
Просмотров 2166 месяцев назад
Mastering Medical Device Standards: The Essential Guide for All Device Types
Wearable Medical Devices Transforming Healthcare
Просмотров 536 месяцев назад
Wearable Medical Devices Transforming Healthcare
ISO 14971 and the risk management of medical devices
Просмотров 5848 месяцев назад
ISO 14971 and the risk management of medical devices
IEC 62366 1 Usability Engineering for Medical Devices
Просмотров 4268 месяцев назад
IEC 62366 1 Usability Engineering for Medical Devices
The sterilisation of medical devices and the methods used
Просмотров 6528 месяцев назад
The sterilisation of medical devices and the methods used
Medical Device Labelling - ISO 15223 Medical Symbols
Просмотров 2958 месяцев назад
Medical Device Labelling - ISO 15223 Medical Symbols
The Electrical Safety of Medical Devices
Просмотров 4889 месяцев назад
The Electrical Safety of Medical Devices
Clinical Evaluation of Medical Devices
Просмотров 6539 месяцев назад
Clinical Evaluation of Medical Devices
Regulating AI (Artificial Intelligence) Medical Devices
Просмотров 869 месяцев назад
Regulating AI (Artificial Intelligence) Medical Devices
Identifying if a product is an IVD under EU IVDR 2017/746
Просмотров 569 месяцев назад
Identifying if a product is an IVD under EU IVDR 2017/746
Navigating EU Regulations: Is My Product a Medical Device?
Просмотров 6410 месяцев назад
Navigating EU Regulations: Is My Product a Medical Device?