> If the auditee loses a certification / accreditation, that’s also a loss of bu...

		ekianjo on Jan 15, 2020 \| parent \| context \| favorite \| on: Glia – High-quality low-cost open source medical h... > If the auditee loses a certification / accreditation, that’s also a loss of business for the auditor. A bunch of simple medical devices (Class I in the EU) are self-certified by manufacturers, and require no seal of approval before commercialization.

Because they can cause no harm, otherwise they would be in Class II.