WMDO
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Clinical Evaluation Report: Review for Regulatory Professionals
The course provides detailed insight into clinical evaluation report reviews by Notified Body and Regulatory reviewers. It particularly focuses on the aspects of clinical evaluation reports that notified bodies and regulatory authority reviewers pay attention to during the reviewing process.
The course complies with the requirements of the Medical Device Regulations, MEDDEV 2.7.1 rev 4 and the NBOG checklist for auditing clinical investigations.
#clinicalevaluation #MEDDEV#regulatoryprofessionals
Learn more at: wmdo.org/course-detail.aspx?id=63
Переглядів: 124

Відео

The European Medical Device New Regulation 2017/745
Переглядів 76Рік тому
This 11-part course covers all aspects of the EU MDR 2017/745 in a comprehensive manner, providing practical guidance and identifying major differences with the current MDD/AIMD on the following topics: Basics and background of EU medical device regulations, including roles and responsibilities of key players (such as notified bodies and competent authorities) Structure of the EU MDR and other ...
ISO 14155:2020 - A Summary Review
Переглядів 248Рік тому
This course provides a condensed yet inclusive summary review of the latest version of the ISO 14155 standard. It covers the following topics: When to apply ISO 14155 requirements The basics of ethics requirements Essential tasks and elements needed during the preparation, conduct, and closing of clinical investigations
Applying GDPR to Medical Devices Clinical Investigations
Переглядів 14Рік тому
Untangle the mysteries about GDPR for medical device clinical investigations. The course provides a detailed review of the GDPR requirements and how these apply to medical device investigations. The different parties involved i.e. controllers, processors and data protection officers and their responsibilities are described. The course provides a comprehensive outline of how companies should app...
EU-MDR 2017/745 Review for Clinical Professionals
Переглядів 31Рік тому
This comprehensive review of the EU-MDR 2017-745 focusses on the particular parts of the regulation that need understanding and compliance by clinical professionals during the planning, execution and archiving of clinical investigations whether pre- or post-market. The course outlines the following regarding EU-MDR 2017-745: A thorough explanation of the requirements for clinical professionals ...
Clinical Evaluation for Market Approval
Переглядів 65Рік тому
Manufacturers planning to market their devices in Europe are required to provide clinical data in line with the European Medical Device Regulation This intensely comprehensive course on Clinical Evaluation for Market Approval will empower you with the essential information, requirements and guidelines you need to successfully and accurately conduct clinical evaluation either as part of the comp...
Data from Prospective Clinical Investigation for CE-Mark: Review for Regulatory Professionals
Переглядів 2314 роки тому
Course Description: The course provides detailed insight into clinical investigation reviews for both the CE-Mark and post-market surveillance program. It particularly focuses on the aspects of clinical investigation reviews that notified bodies and regulatory authority reviewers pay attention to during the reviewing process. This course complies with the requirements of the EU Medical Device R...
Clinical Evaluation Report: Review for Regulatory Professionals
Переглядів 7294 роки тому
Course Description: The course provides detailed insight into clinical evaluation report reviews by Notified Body and Regulatory reviewers. It particularly focuses on the aspects of clinical evaluation reports that notified bodies and regulatory authority reviewers pay attention to during the reviewing process. The course complies with the requirements of the Medical Device Regulations, MEDDEV ...
Conducting Medical Device Clinical Investigations in Switzerland
Переглядів 3595 років тому
This course provides a comprehensive overview of the Swiss regulatory and ethical requirements for conducting clinical investigations with medical devices in the pre-and post-market phases. This course covers the following topics: Members of the Swiss Competent Authority (Swissmedic) and Swiss Ethics Committees Laws concerning medical devices and clinical investigations with medical devices, in...
Pre-Market Approval for Medical Device in China
Переглядів 3915 років тому
Course Description: This course offers you an excellent overview of the Chinese regulatory system for medical devices and outlines the pathways to access the medical device market in China. Starting with a detailed explanation of the Chinese regulatory system, this course also examines the process for registration of your devices including the post-market surveillance requirements you will need...
ISO 14155_课程1_范围
Переглядів 1126 років тому
Course Description: 本次课程阐述了ISO14155标准的背景以及如何与其它国际法规文件融合应用。ISO14155适用于所有类型的医疗器械临床试验,并应用了大量的参考文献。 本课程还探讨了进行临床试验所需的其他强制性标准。 观看课程预告 Learn more at : wmdo.org/course-detail.aspx?id=213
Effective Time Management
Переглядів 436 років тому
Course Description: This course demonstrates how to analyze time consumption and identifies specific ways to improve time management, with the goal of becoming more productive on and off the job, enhancing work quality, and reducing stress. It covers the following topics: Setting goals Establishing priorities Scheduling tools Handling interruptions Meeting skills Delegating tasks Overcoming pro...
Effective Time Management
Переглядів 326 років тому
Effective Time Management
MEDDEV 2.7.1 rev 4 versus rev 3 - A Gap Analysis
Переглядів 2,5 тис.7 років тому
Course Description: The course provides detailed review of the new requirements introduced by the MEDDEV 2.7.1 rev 4 compared to the revision 3. In addition to this gap analysis between the 2 revisions, the new elements of the European Medical Device Regulation (MDR) have also been included. The course helps notified body reviewers understand the essential new elements that both MEDDEV 2.7.1 re...
IVD Australia: Making Applications for Inclusion on the ARTG
Переглядів 1647 років тому
Course Description: This course examines the process of creating applications for IVD devices on the Australian Register of Therapeutic Goods (ARTG). It also reviews the requirements for manufacturer certification and the TGA application process. Additionally, this course explains the necessary course of action when given either a positive or negative response from the TGA, and also outlines th...
IVD Australia: Basics for including an IVD on the ARTG
Переглядів 777 років тому
IVD Australia: Basics for including an IVD on the ARTG
internal auditor
Переглядів 9097 років тому
internal auditor
What’s changing in Rev 4 of MEDDEV 2.7.1
Переглядів 3747 років тому
What’s changing in Rev 4 of MEDDEV 2.7.1
Clinical Evaluation report of Existing data for CE-mark: review for regulatory professionals
Переглядів 1,3 тис.7 років тому
Clinical Evaluation report of Existing data for CE-mark: review for regulatory professionals
The ASEAN Common Submission Dossier Template (CSDT) and Its Contents
Переглядів 3,3 тис.8 років тому
The ASEAN Common Submission Dossier Template (CSDT) and Its Contents
The Australian Regulatory System for Medical Devices
Переглядів 3508 років тому
The Australian Regulatory System for Medical Devices
ISO 13485 - Medical Devices Quality Management Systems Requirements for Regulatory Purposes
Переглядів 9 тис.8 років тому
ISO 13485 - Medical Devices Quality Management Systems Requirements for Regulatory Purposes
singapore
Переглядів 888 років тому
singapore
Applied Project Management: Project Realization
Переглядів 1939 років тому
Applied Project Management: Project Realization
Applied Project Management: Risks and Opportunities
Переглядів 1659 років тому
Applied Project Management: Risks and Opportunities
Applied Project Management: Project Environment
Переглядів 1849 років тому
Applied Project Management: Project Environment
Applied Project Management: Project Organization
Переглядів 2639 років тому
Applied Project Management: Project Organization
Applied Project Management: Project Planning
Переглядів 4769 років тому
Applied Project Management: Project Planning
Applied Project Management: Project Leadership
Переглядів 499 років тому
Applied Project Management: Project Leadership
Applied Project Management: Visualizing
Переглядів 1499 років тому
Applied Project Management: Visualizing

КОМЕНТАРІ

  • @jeffpoole8404
    @jeffpoole8404 Рік тому

    😚 *promosm*

  • @majdiayoub2500
    @majdiayoub2500 2 роки тому

    this video is really informativ and thanks to share, can i ask how can i wach other videos

  • @isometricconsulting2948
    @isometricconsulting2948 2 роки тому

    This is a very informative, concise video.

  • @douglassantos9611
    @douglassantos9611 2 роки тому

    the video image is too poor, you need to fix it more

  • @raphaelmensah6278
    @raphaelmensah6278 3 роки тому

    Please may I know the significance of 810nm wavelength and it's application in medicine. medical equipment and radiotherapy?

  • @yogesh.m8727
    @yogesh.m8727 3 роки тому

    expansion of EEC/EC?

  • @anacarmo6205
    @anacarmo6205 3 роки тому

    Dohudj

  • @colleenbonniwell4226
    @colleenbonniwell4226 3 роки тому

    Sixth grade english!

  • @nicholasturney7432
    @nicholasturney7432 3 роки тому

    Bioethics/Covid19 After Covid19/Bioethics enquires will take place whether healthcare had adequate policies/strategies to deal with unique life and death decisions. One important area will be patient case management and documentation. ua-cam.com/video/XBTt-V6wX88/v-deo.html

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  • @anoopbaghel7866
    @anoopbaghel7866 4 роки тому

    Whether infectious disease positive serum like HIV, HBV, HCV positive serum which are to be supplied to the IVD kits manufacturer are regulated in EUROPE and other GHTF countries..?

  • @anoopbaghel7866
    @anoopbaghel7866 4 роки тому

    Whether infectious disease positive serum like HIV, HBV, HCV positive serum which are to be supplied to the IVD kits manufacturer are regulated in EUROPE and other GHTF countries..?

  • @anoopbaghel7866
    @anoopbaghel7866 4 роки тому

    Whether infectious disease positive serum like HIV, HBV, HCV positive serum which are to be supplied to the IVD kits manufacturer are regulated in US and other GHTF countries..?

  • @daksharaghwani6322
    @daksharaghwani6322 4 роки тому

    Back brown is very sexy

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    @daksharaghwani6322 4 роки тому

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    @merylrichard2323 4 роки тому

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  • @AshishSingh-gd9wo
    @AshishSingh-gd9wo 4 роки тому

    How CRA verify source data ? How he get source data? he visit site in person or remotely?

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  • @silkygupta3452
    @silkygupta3452 4 роки тому

    For firms involved in the Production or Trading of Medical Devices/Equipments, towards better Branding and creating new business, VQMS PVT LTD provides ISO 13485 MEDICAL DEVICES CERTIFICATION consultancy. For more information, please fill out this Google form. We'll get back to you. docs.google.com/forms/d/e/1FAIpQLSfOdtxIGXe78ewLQRs4y_SBK7wYqUI2k4hfxCRR0MQMKNF2Bg/viewform?usp=sf_link

  • @Blendershick
    @Blendershick 4 роки тому

    Привет как Дистанционка?

  • @ВикторСтепанов-и7н

    Всем привет

  • @MattBiden
    @MattBiden 4 роки тому

    and its failing

    • @davidescristofaros2241
      @davidescristofaros2241 4 роки тому

      It's not failing because it's a public healthcare system though

    • @MattBiden
      @MattBiden 4 роки тому

      @@davidescristofaros2241 Are you being sarcastic?

    • @davidescristofaros2241
      @davidescristofaros2241 4 роки тому

      @@MattBiden no I'm not

    • @MattBiden
      @MattBiden 4 роки тому

      @@davidescristofaros2241 How does your logic work believing that public services can't fail?

    • @davidescristofaros2241
      @davidescristofaros2241 4 роки тому

      @@MattBiden I'm not saying that public services can't fail but our healthcare's problems are not due only to the fact that it's a public service. We've cut fundings for healthcare for years to fund welfarists campaigns of politicians that promise money in change of votes. We're corrupted, have a big ass debt and keep giving money for votes. No fundings=shitty public services

  • @nandakumarp9179
    @nandakumarp9179 4 роки тому

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  • @nandakumarp9179
    @nandakumarp9179 4 роки тому

    💃💉💊 PRODUCTS... TESTING... VALIDATION... MARKETING]]⛳☘️⛳[[NANDAKUMAR DEVELOPMENT OFFICER LIC KALOOR ERANAKULAM]]

  • @lalasun8571
    @lalasun8571 4 роки тому

    Manufactured by a team of excellent equipment experts: Ethylene oxide sterilizer(Medical Instruments).Welcome to contact me,if you need it. E-mail:LalaSuen@@t whatsapp:+86 18403905767 Henan Huatai Intelligent Equipment Group----Wishing you peace and health

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    @armanislam7469 4 роки тому

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  • @snehapriya300
    @snehapriya300 5 років тому

    Global In-Vitro Diagnostics Market size is projected to reach approximately $ XX Billion by the end of 2024 with a CAGR close to X% from $XX Billion in 2018 during the forecast timeline 2018-2024. Request free sample @ www.envisioninteligence.com/industry-report/global-vitro-diagnostics-market/?

  • @davidyoung7654
    @davidyoung7654 5 років тому

    Nice video. There are good articles that can help someone I am sure: www.qmswrapper.com/blog

  • @mohansharma9505
    @mohansharma9505 5 років тому

    In Vitro Diagnostics Industry Present Scenario and the Growth Prospects with Forecast 2024 Get free sample report here: bit.ly/2RVMJIa The factors driving the United States in vitro diagnostics market are, growing population of boomers and prevalence of the chronic and contagious diseases, growing preference of the point-of-care testing diagnostics devices and government initiatives to promote healthcare domain etc.

  • @mrfrhealthcare6991
    @mrfrhealthcare6991 6 років тому

    Really Good information we also provide some information at ua-cam.com/video/V31Ez6I-I60/v-deo.html

  • @Vision267
    @Vision267 6 років тому

    Do we have to comply product packaging also to rohs

  • @davidhillguildford1478
    @davidhillguildford1478 6 років тому

    Great job in doing this video. Thank you for sharing this information. Sharing with you a video of David Hill Guildford about this topic. ua-cam.com/video/f-NFXMZlnEk/v-deo.html

  • @creativehumantouch1618
    @creativehumantouch1618 6 років тому

    good ,please fully explain .

  • @delvehealth5203
    @delvehealth5203 6 років тому

    ua-cam.com/video/nMXtO3PIgVY/v-deo.html

  • @zra8997
    @zra8997 7 років тому

    Sterilization of medical and Hygienic products are very important. A good method for sterilization must be safe and available for a long time because we need to sterile our special products every day. Ethylene Oxide is flammable, unsafe and expensive. There are a lot of better methods and equipment to do this vital step of manufacturing.

    • @liby54500
      @liby54500 2 роки тому

      and what are better method is your Devices are thermosensitive?