510(k) submissions

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 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.