Innovation requires freedom of thought and research directions to investigate ideas and
concepts. Regulation ensures that control is applied and can be considered to limit the
experimental process.
Taking a Medical Device or Implant (NB one only) that has been developed or significantly
modified in the last 5 years describe the innovation versus the regulation (US FDA or
European CE marking scheme or both) needed to get it to patient use. You may want to
consider something related to your project or from a totally different area of Medical
Devices and Implants.
• Ensure you provide a clear description of both the innovation process applied to
your chosen medical device or implant and the regulations/regulation process
needed to allow it to reach patients.
• Clearly indicate the major elements needed for the approval of the medical device
or implant.
• Clearly explain regularity issues that are specific to this development that might
not be present in other areas of medical devices or implants
I have order this piece of coursework before, however I was not satisfied with the result and I would like you
to edit it for me such that:
Could you please include more about European CE marking scheme and discuss more the relation
between the innovation and regulation rather than just explaining what the regulations are and what they
mean.
Also, could you discuss it in relation to a medical device such as an implant, rather than drugs.
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