510(k) submissions

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 510(k) submissions.

2. P2

   Executes standard 510(k) submissions activities accurately within established controls and escalates exceptions.

3. P3

   Owns complex 510(k) submissions cases/processes, improves controls and coaches colleagues.

4. P4

   Sets cross-team standards and governance for 510(k) submissions, integrating risk, metrics and stakeholder needs.

5. P5

   Defines enterprise strategy or external practice for 510(k) submissions and develops other experts.