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As with assignment #1, 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):
1. Introduction (1 paragraph)
a) 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.
2. Outline the Key Players (2-3 paragraphs)
a) Regulatory Oversight for Devices: In each of the 2 countries (US, Spain), what
regulatory bodies are tasked with providing direct oversight to:
i) Medical Device pre-market development
ii) 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)
3. FDA Medical Device Requirements (3-4 paragraphs)
a) 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.
b) 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).
i) What types of medical devices fall under this part of the code?
ii) What are the pharmacovigilance/safety relevant concepts introduced in
used to seeing with drugs/biologics?
1. What are the expedited reporting details? What events meet these criteria and what are the
4. European Commission Device Requirements (3-4 paragraphs)
a) 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
b) Identify and outline, in your own words, the key areas under the EU MDR that pertain to
pre-market medical device clinical investigations:
i) What are the pharmacovigilance/safety relevant concepts introduced in the EU
ii) What safety-related definitions are introduced that are different from what
your company is used to seeing with drugs/biologics?
timeframes, if any?
1. 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
5. Conclusion/Next Steps (1-2 paragraphs)
a) 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?
b) 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
Last week assignment attached