If you are going to make medical grade electronics I really think that
you
do need knowledge (perhaps not exhaustive though) about the regulatory
procedures and standards. Why not get that from the horse's mouth - The
standards. You should have read the applicable standards so that you,
at
least, have some feel for what is different from standard industrial or
residential/commercial electronics. I have not done this myself but you
may need to implement safety measures by redundancy, not use a part
above a certain percent of its rated power/voltage/current values
and/or
use increased creepage and clearance to mention some.

This way you won't have to guess and risk doing things all over again
when it comes back from regulatory compliance testing.

I also think that you must follow some quality assurance protocol, both
for production and design and development. For design and development=20
it means that you need to do risk assessment and work with a well
documented requirement specification which also states the applicable
standards, and you can't do that without having (access to) the
standards.=20

/Ruben

On Mon, 23 Nov 2015 23:24:35 -0800, Jesse Lackey
<jsl-ml@celestialaudio.com> wrote:
> Hi all, after 10 years of freelance (!), I have taken a full-time "real=20
> job"!  I'm now the main EE guy at this company that makes pneumatically=20
> driven cutters for eye surgery.  Most of what they do is more mechanical=
=20
> than electrical, but they have a few (aging, created a number of years=20
> ago) custom electronic designs.  I'm updating those and moving forward=20
> on a number of fronts in the near term.
>=20
> I'm looking for a good book for electonic design in the medical=20
> industry.  I don't think I'll need some exhaustive discussion of=20
> regulatory procedure (doing the official compliance documentation will=20
> be someone else or another company), but more along the lines of=20
> numerous good tips/guidelines/gotchas.
>=20
> Over the last 10 years, my EE skills evolved from basic to senior, in no=
=20
> small part to the help and discussion on PICList, and I want to thank=20
> you all for contributing your time and knowledge to the greater good of=20
> all.  Personally I'm thrilled to have my future efforts go towards the=20
> never ending goal of better medical processes and tools to more people=20
> around the world - and you PICListers have helped make that possible.
>=20
> Cheers all!
> J

--=20
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