Medical device design controls

Qué significa cada nivel

La escala P1–P5 es común a todas las habilidades, pero lo que significa cada nivel cambia según la habilidad. Esto es lo que se espera observar.

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.