Medical device design controls

What each level means

The P1–P5 scale is shared across every skill, but what each level means changes with the skill. This is what it looks like in practice.

1. P1

   Describes the process, controls, stakeholders and basic decisions involved in Medical device design controls.

2. P2

   Executes standard Medical device design controls activities accurately within established controls and escalates exceptions.

3. P3

   Owns complex Medical device design controls cases/processes, improves controls and coaches colleagues.

4. P4

   Sets cross-team standards and governance for Medical device design controls, integrating risk, metrics and stakeholder needs.

5. P5

   Defines enterprise strategy or external practice for Medical device design controls and develops other experts.