Frequently Asked Questions

How is this different from hiring a consultant?
Consulting usually involves project-based deliverables. This service is not about writing procedures or running submissions on your behalf. It’s about having an experienced advisor you can call on when you need clarity, perspective, or a second set of eyes.

Who is this service for?
Regulatory and quality leaders in medical device and IVD companies — from managers building capability to executives juggling multiple markets and teams. It works best for professionals who carry responsibility for decisions but don’t always have someone outside the organization to pressure-test ideas with.

How do the calls work?
We set aside dedicated time each month based on the tier you choose. Calls are scheduled in advance, and you can bring your own agenda: regulatory questions, quality system challenges, audit prep, or team discussions.

What if I need more time or extra calls?
If a situation comes up that requires more support, we can schedule additional calls outside your plan. The goal is flexibility without surprises.

Can I include my team?
Yes — at the higher tiers, you can bring team members into the sessions. This is often helpful for training, mentoring, and building internal capability.

Do you provide written deliverables or templates?
No — this service is focused on conversations, feedback, and guidance. If you need full consulting deliverables, we can discuss that separately.

How do payments work?
Services are subscription-based, billed monthly. You can cancel at any time if it no longer fits your needs.