In the previous assignment you assigned a device classification to three devices produced in the department of Biomedical Engineering;The HemoSep blood cell recovery and concentration system
In the previous assignment you assigned a device classification to three devices produced in the department of Biomedical Engineering;The HemoSep blood cell recovery and concentration system
A polymeric paediatric heart valve.
The Wound Sense wound hydration monitoring system.In this second assignment you will consider the regulatory pathway for these devices further. In particular please consider the following regulatory issues: Determine the potential conformity routes for all 3 products.
Determine whether a notified body will be required and why.
Consider whether a quality system be required by the notified body.You should use the lecture notes from module BE920 in considering these issues together with web sources provided in the notes and any other sources you may find useful in compiling this report. The sources should be referenced and the report should be concise and no more than 2 A4 pages in length.
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