Regulations

Class I: low risk, non invasive

Class IIa: low to moderate risk, non-invasive or invasive for short term application

Class IIb: moderate to high risk, implantable/invasive for long term use

Class III: high risk, implantable/ highly invasive for lomg term use

Class A (e.g. clinical chemistry analysis)

Class B (e.g. pregnancy self testing)

Class C(e.g. blood glucose self testing)

Class D (e.g. Hepatits B blood donor screening)

Planning

Implemenation

Controlling

Customer focus,

leadership,

engagement,

process approach,

evidence based decisions

relationship management