Northeastern University International Medical Device Approval Process Discussion

Question Description

This study has 4 questions and should be answered in short answer question form not an essay.

Question #1:

Your technology company has designed a tiny electronic device that functions as a skin-proximal glucose sensor, which can be incorporated into a wristwatch or smart clothing. Together with the companion smartphone app, which processes incoming signals sent from the device to a patient’s phone, your product is able to provide continuous monitoring of blood glucose levels to diabetic patients in real-time. This greatly facilitates the task of keeping blood glucose levels in check and has the potential to vastly improve the quality of live and longevity of those with this debilitating condition. What steps do you need to take to gain the approval in Singapore for this new gadget?

Question #2:

Your same technology company has designed a micro-sized implantable insulin pump that communicates with the same external smartphone app as the glucose sensor and coordinates delivery of insulin in real-time with measurements of elevated glucose levels. How would you go about having this additional device approved for use in Canada? Do you need to conduct clinical trials to gain approval for your device?

Question #3:

We are currently at the dawn of a transformative era in cancer treatment, that of cancer-immunotherapy, in which a patient’s immune system is re-trained to attack the patient’s own cancer, via several increasingly successful strategies.Your medical device company has created a machine to isolate and separate immune cells from a patient’s blood, expand and enrich them for those activated to attack cancer cells, then deliver them back to the patient’s bloodstream. You are in charge of developing a strategy for the company to achieve registration of this machine in both Canada and Singapore and have to present a roadmap to the board of directors. What are the main points on your roadmap and what regulatory hurdles might you face?

Question #4:

This is the first year for Your company to have the first Medical Device Single Audit Program-MDSAP. As head of Regulatory Affairs for this company, what guidance or/and requirements do you need to consider for the company to have a successful single audit program? What are the steps should you be making to assure sure all departments comply?

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