Jesse, In the medical field, One of the most important part of the design is the F= ailure Mode and Effects Analysis. You need to know what will happen when on= e element fail, and make sure that the failure is safe for the human body near the instrument. My $0.02, Jean-Paul AC9GH > On Nov 24, 2015, at 3:28 AM, rubenjonsson@bredband.net wrote: >=20 > 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. >=20 > This way you won't have to guess and risk doing things all over again > when it comes back from regulatory compliance testing. >=20 > 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 >=20 > /Ruben >=20 > On Mon, 23 Nov 2015 23:24:35 -0800, Jesse Lackey > 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 > --=20 > http://www.piclist.com/techref/piclist PIC/SX FAQ & list archive > View/change your membership options at > http://mailman.mit.edu/mailman/listinfo/piclist --=20 http://www.piclist.com/techref/piclist PIC/SX FAQ & list archive View/change your membership options at http://mailman.mit.edu/mailman/listinfo/piclist .