A detailed referenced pestle analysis done for medical device(standalone software) for the U.S.A and Europe.
It must include
European Market
The general Medical Device Directive (MDD) 93/42/EEC, which has been amended by 2007/47/EC governs this device within the EU market.
US Market
In the case of the US, the Food and Drug Administration (FDA) issues the pertinent regulation through a series of official channels, including the Code of Federal Regulation (CFR) Title 21, Chapter I, Subchapter H, Part 820 (ref. Figure 1).
There is no need to discuss intellectual Property rights under legal heading