Traceability, design history files and change control turn a standard build into a regulated one. What medical OEMs should expect from an EMS partner before the first board is placed.
A reflow profile that suits one assembly will cold-solder the next. How thermal mass, component height and paste chemistry drive the curve, and what a mis-set profile costs further down the line.
Moisture, salt fog and vibration end more boards than component failure does. When to specify a conformal coating, when potting is the better answer, and what each choice costs you in reworkability.
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