{"id":7551,"date":"2022-05-09T22:47:14","date_gmt":"2022-05-09T22:47:14","guid":{"rendered":"https:\/\/highclasswriters.com\/blog\/?p=7551"},"modified":"2022-05-09T22:47:15","modified_gmt":"2022-05-09T22:47:15","slug":"executive-summary-overview-of-the-basics-of-pre-market-medical-device-reporting-requirements","status":"publish","type":"post","link":"https:\/\/highclasswriters.com\/blog\/executive-summary-overview-of-the-basics-of-pre-market-medical-device-reporting-requirements\/","title":{"rendered":"Executive Summary \u2013 Overview of the Basics of Pre-market Medical Device Reporting Requirements"},"content":{"rendered":"\n

Writing Assignment #1
RGA6212 Spring 2022: Executive Summary \u2013 Overview of the Basics of
Pre-market Medical Device Reporting Requirements
Assignment specifications:
\u2022 ASSIGNMENT AVAILABLE: 25 April 2022 (Week 3)
\u2022 ASSIGNMENT DUE: May 18, 2022, 11:59 PM
\u2022 ASSIGNMENT LENGTH:
\u25e6 5-7 written pages (or more, if needed, but not to exceed 10) but NOT
Including figures or tables or references
\u2022 DELIVERY TO INSTRUCTOR: Via Canvas link for Written Assignment #1
\u2022 GRADE PERCENTAGE: 10.0%
Assignment description:
In completing Writing Assignment #1 for RGA6212 students will have the opportunity to:
\u2022 Simulate the role of a Regulatory Affairs Manager in identifying the key
differences between pharmacovigilance practices for drugs\/biologics vs. medical
devices
\u2022 Demonstrate understanding of the relevant Safety Reporting guidelines for drugs
and devices in the US and EU, specifically
\u2022 Apply knowledge of the relevant Safety Reporting regulations for drugs,
biologics, and devices in a real-world setting
You are a Sr Manager of Regulatory Affairs at a small, emerging biotechnology
company that is looking to develop a new medical device for the treatment of atrial
fibrillation, also known as irregular\/rapid heartbeat. To-date, your company only has
experience with the pharmacovigilance practice related to the development of drugs\/
biologics. Your device is similar to a pacemaker in that it is an implantable electronic
device that will be placed in a certain location within the heart muscle of a patient and
will be left there for several years to regulate the heartbeat.
Your company is preparing to embark on medical device trials in the United States and
Spain.
Your task is to provide the following information to your colleagues in the form of an
executive summary (incorporation of figures and graphs HIGHLY encouraged):<\/p>\n\n\n\n

  1. Introduction (1 paragraph)<\/li>
  2. Provide a general introduction for your colleague to explain the purpose of
    this briefing document and what types of information you plan to include
    and why.<\/li>
  3. Outline the Key Players (2-3 paragraphs)<\/li>
  4. Regulatory Oversight for Devices: In each of the 2 countries (US,
    Spain), what regulatory bodies are tasked with providing direct oversight
    to:<\/li>
  5. Medical Device pre-market development<\/li>
  6. Medical Device Pharmacovigilance – hint: In Spain, you will need to
    address this on two levels: The European Commission\u2019s role and
    the role of The Spanish Agency of Medicines and Medical Devices
    (AEMPS)<\/li>
  7. FDA Medical Device Requirements (3-4 paragraphs)<\/li>
  8. Describe the different FDA classifications for medical devices. Be
    sure to clearly outline how risk plays a role in the classification of
    devices and explain why your company\u2019s device, which is intended
    to regulate the heartbeat, will most likely be classified as a Class III
    device.<\/li>
  9. Identify and outline, in your own words, the key areas under the
    Code of Federal Regulations that pertain to pre-market medical
    device pharmacovigilance as conducted under an Investigation
    Device Exemption (IDE).<\/li>
  10. What types of medical devices fall under this part of the
    code?<\/li>
  11. What are the pharmacovigilance\/safety-relevant concepts
    introduced in the code?
    \u2022 What safety-related definitions are introduced that are different from what your
    company is used to seeing with drugs\/biologics?<\/li>
  12. What are the expedited reporting details? What events meet these criteria and
    what are the timeframes?<\/li>
  13. European Commission Device Requirements (3-4 paragraphs)<\/li>
  14. Describe the different EC classifications for medical devices. In what ways
    are they similar or different from those employed by the FDA? Be sure to
    clearly outline how risk plays a role in the classification of devices and
    explain why your company\u2019s device, which is intended to regulate the
    heartbeat, will most likely be classified as a Class III device.<\/li>
  15. Identify and outline, in your own words, the key areas under the EU MDR
    that pertain to pre-market medical device clinical investigations:<\/li>
  16. What are the pharmacovigilance\/safety-relevant concepts
    introduced in the EU MDR?<\/li>
  17. What safety-related definitions are introduced that are different from
    what your company is used to seeing with drugs\/biologics?
    \u2022 What are the expedited reporting details? What events meet these criteria and
    what are the timeframes, if any?<\/li>
  18. Optional: While Spain is an EU member state and therefore comes under the EC
    medical device rules, what role with Spain\u2019s Competent Authority, The Spanish
    Agency of Medicines and Medical Devices (AEMPS), play with respect to safety
    reporting for the medical device while it is undergoing clinical trials in Spain<\/li>
  19. Conclusion\/Next Steps (1-2 paragraphs)<\/li>
  20. What resources will you use to help your company understand the
    pharmacovigilance regulations related to clinical trials of medical devices
    in the US and EU?<\/li>
  21. Will you recommend any specific vendors to help manage safety reporting
    during clinical trials of your device? Feel free to take this in a creative
    direction
    The entire assignment should be 5-7 written pages (or more, if needed, but not to
    exceed 10) but NOT Including figures or tables, or references. Any graphs or figures
    that you choose to include must be properly cited and do not count against your page
    count. Please submit your assignment through the link provided in Canvas. Please
    remember that this assignment is worth 10.0% of your final grade for the course. Late
    submissions will not be accepted without prior permission from the Instructor.<\/li><\/ol>\n","protected":false},"excerpt":{"rendered":"

    Writing Assignment #1RGA6212 Spring 2022: Executive Summary \u2013 Overview of the Basics ofPre-market Medical Device Reporting RequirementsAssignment specifications:\u2022 ASSIGNMENT AVAILABLE: […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[1],"tags":[],"class_list":["post-7551","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"acf":[],"yoast_head":"\nExecutive Summary \u2013 Overview of the Basics of Pre-market Medical Device Reporting Requirements - 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