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Medical Device for Atrial Fibrillation Treatment
Medical Device for Atrial Fibrillation Treatment
Order ID 53563633773 Type Essay Writer Level Masters Style APA Sources/References 4 Perfect Number of Pages to Order 5-10 Pages Description/Paper Instructions
Medical Device for Atrial Fibrillation Treatment
I need help with a Business Law question. All explanations and answers will be used to help me learn.
Simulate the role of a Regulatory Affairs manager in identifying the key differences between pharmacovigilance practices for drugs/biologics vs. medical devices
Demonstrate understanding of the relevant Safety Reporting guidelines for drugs and devices in the US and EU, specifically
Apply knowledge of the relevant Safety Reporting regulations for drugs, biologics, and devices in a real-world setting
Imagine 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):
Medical Device for Atrial Fibrillation Treatment
Introduction (1 paragraph)
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.
Outline the Key Players (2-3 paragraphs)
Regulatory Oversight for Devices: In each of the 2 countries (US, Spain), what regulatory bodies are tasked with providing direct oversight to:
Medical Device pre-market development
Medical Device Pharmacovigilance – hint: In Spain, you will need to address this on two levels: The European Commission’s role and the role of The Spanish Agency of Medicines and Medical Devices (AEMPS)
FDA Medical Device Requirements (3-4 paragraphs)
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’s device, which is intended to regulate the heartbeat, will most likely be classified as a Class III device.
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).
What types of medical devices fall under this part of the code?
What is the pharmacovigilance/safety relevant concepts introduced in the code?
What safety-related definitions are introduced that are different from what your company is used to seeing with drugs/biologics?
What are the expedited reporting details? What events meet these criteria and what are the timeframes?
European Commission Device Requirements (3-4 paragraphs
Medical Device for Atrial Fibrillation Treatment
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’s device, which is intended to regulate the heartbeat, will most likely be classified as a Class III device.
Identify and outline, in your own words, the key areas under the EU MDR that pertain to pre-market medical device clinical investigations:
What is the pharmacovigilance/safety relevant concepts introduced in the EU MDR?
What safety-related definitions are introduced that are different from what your company is used to seeing with drugs/biologics?
What are the expedited reporting details? What events meet these criteria and what are the timeframes, if any?
Optional: While Spain is an EU member state and therefore comes under the EC medical device rules, what role with Spain’s 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
Conclusion/Next Steps (1-2 paragraphs)
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?
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.
Medical Device for Atrial Fibrillation Treatment
RUBRIC
QUALITY OF RESPONSE NO RESPONSE POOR / UNSATISFACTORY SATISFACTORY GOOD EXCELLENT Content (worth a maximum of 50% of the total points) Zero points: Student failed to submit the final paper. 20 points out of 50: The essay illustrates poor understanding of the relevant material by failing to address or incorrectly addressing the relevant content; failing to identify or inaccurately explaining/defining key concepts/ideas; ignoring or incorrectly explaining key points/claims and the reasoning behind them; and/or incorrectly or inappropriately using terminology; and elements of the response are lacking. 30 points out of 50: The essay illustrates a rudimentary understanding of the relevant material by mentioning but not full explaining the relevant content; identifying some of the key concepts/ideas though failing to fully or accurately explain many of them; using terminology, though sometimes inaccurately or inappropriately; and/or incorporating some key claims/points but failing to explain the reasoning behind them or doing so inaccurately. Elements of the required response may also be lacking. 40 points out of 50: The essay illustrates solid understanding of the relevant material by correctly addressing most of the relevant content; identifying and explaining most of the key concepts/ideas; using correct terminology; explaining the reasoning behind most of the key points/claims; and/or where necessary or useful, substantiating some points with accurate examples. The answer is complete. 50 points: The essay illustrates exemplary understanding of the relevant material by thoroughly and correctly addressing the relevant content; identifying and explaining all of the key concepts/ideas; using correct terminology explaining the reasoning behind key points/claims and substantiating, as necessary/useful, points with several accurate and illuminating examples. No aspects of the required answer are missing. Use of Sources (worth a maximum of 20% of the total points). Zero points: Student failed to include citations and/or references. Or the student failed to submit a final paper. 5 out 20 points: Sources are seldom cited to support statements and/or format of citations are not recognizable as APA 6th Edition format. There are major errors in the formation of the references and citations. And/or there is a major reliance on highly questionable. The Student fails to provide an adequate synthesis of research collected for the paper. 10 out 20 points: References to scholarly sources are occasionally given; many statements seem unsubstantiated. Frequent errors in APA 6th Edition format, leaving the reader confused about the source of the information. There are significant errors of the formation in the references and citations. And/or there is a significant use of highly questionable sources. 15 out 20 points: Credible Scholarly sources are used effectively support claims and are, for the most part, clear and fairly represented. APA 6th Edition is used with only a few minor errors. There are minor errors in reference and/or citations. And/or there is some use of questionable sources. 20 points: Credible scholarly sources are used to give compelling evidence to support claims and are clearly and fairly represented. APA 6th Edition format is used accurately and consistently. The student uses above the maximum required references in the development of the assignment. Grammar (worth maximum of 20% of total points) Zero points: Student failed to submit the final paper. 5 points out of 20: The paper does not communicate ideas/points clearly due to inappropriate use of terminology and vague language; thoughts and sentences are disjointed or incomprehensible; organization lacking; and/or numerous grammatical, spelling/punctuation errors 10 points out 20: The paper is often unclear and difficult to follow due to some inappropriate terminology and/or vague language; ideas may be fragmented, wandering and/or repetitive; poor organization; and/or some grammatical, spelling, punctuation errors 15 points out of 20: The paper is mostly clear as a result of appropriate use of terminology and minimal vagueness; no tangents and no repetition; fairly good organization; almost perfect grammar, spelling, punctuation, and word usage. 20 points: The paper is clear, concise, and a pleasure to read as a result of appropriate and precise use of terminology; total coherence of thoughts and presentation and logical organization; and the essay is error free. Structure of the Paper (worth 10% of total points) Zero points: Student failed to submit the final paper. 3 points out of 10: Student needs to develop better formatting skills. The paper omits significant structural elements required for and APA 6th edition paper. Formatting of the paper has major flaws. The paper does not conform to APA 6th edition requirements whatsoever. 5 points out of 10: Appearance of final paper demonstrates the student’s limited ability to format the paper. There are significant errors in formatting and/or the total omission of major components of an APA 6th edition paper. They can include the omission of the cover page, abstract, and page numbers. Additionally the page has major formatting issues with spacing or paragraph formation. Font size might not conform to size requirements. The student also significantly writes too large or too short of and paper 7 points out of 10: Research paper presents an above-average use of formatting skills. The paper has slight errors within the paper. This can include small errors or omissions with the cover page, abstract, page number, and headers. There could be also slight formatting issues with the document spacing or the font Additionally the paper might slightly exceed or undershoot the specific number of required written pages for the assignment. 10 points: Student provides a high-caliber, formatted paper. This includes an APA 6th edition cover page, abstract, page number, headers and is double spaced in 12’ Times Roman Font. Additionally, the paper conforms to the specific number of required written pages and neither goes over or under the specified length of the paper.
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Medical Device for Atrial Fibrillation Treatment
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