Orientation - Getting Started

$375.00

For individual RA/QA leaders who want direct access to an experienced advisor. Orientation provides steady direction, decision support, and a reliable sounding board.

Whats Included:

  • 2 × 30-minute calls each month (60 minutes total)

  • Quick follow-up access for clarifications by email, text, or WhatsApp

  • Ideal for leaders who need clarity and confidence on key regulatory or quality questions

Use Cases:

  1. While drafting a response to FDA or EU authority feedback, a leader wants confirmation that the reply fully addresses the questions before submission.

  2. In preparing for an MDSAP or supplier audit, a manager wants to review their readiness plan and confirm that key risk areas are addressed.

  3. When deciding whether to pursue UKCA marking immediately or delay, an executive needs to talk through regulatory implications and timing trade-offs.

  4. While updating a PMS Plan under EU MDR, a leader wants to validate the scope of activities and check that the approach will stand up to notified body review.

Service fee: $375/month

For individual RA/QA leaders who want direct access to an experienced advisor. Orientation provides steady direction, decision support, and a reliable sounding board.

Whats Included:

  • 2 × 30-minute calls each month (60 minutes total)

  • Quick follow-up access for clarifications by email, text, or WhatsApp

  • Ideal for leaders who need clarity and confidence on key regulatory or quality questions

Use Cases:

  1. While drafting a response to FDA or EU authority feedback, a leader wants confirmation that the reply fully addresses the questions before submission.

  2. In preparing for an MDSAP or supplier audit, a manager wants to review their readiness plan and confirm that key risk areas are addressed.

  3. When deciding whether to pursue UKCA marking immediately or delay, an executive needs to talk through regulatory implications and timing trade-offs.

  4. While updating a PMS Plan under EU MDR, a leader wants to validate the scope of activities and check that the approach will stand up to notified body review.

Service fee: $375/month