4 ms·
The medical certifications are mostly about design & risk control, there isn't really (currently) the same set of toolchain certs you see in e.g. aerospace. So
by ska 3y ago
The medical certifications are mostly about design & risk control, there isn't really (currently) the same set of toolchain certs you see in e.g. aerospace. Some places do use them as a shorthand for "our documentation & testing here is minimal, because we use X certified tools and/or standards" but it isn't required for CFR21 or 13485.