From the first conversation to ongoing support
How it works
We meet for half an hour, by phone or video call. You tell me about the device, the market you are aiming for and your timelines. I tell you what I would do first, and whether I am the right fit for you.
Sometimes I need to see what already exists and what is missing before I can give you an accurate quote. In that case I go through your procedures, your technical file or your most recent audit reports.
I send a proposal that sets out the scope of work, estimated hours and a timeline. I work by the hour, and I offer a fixed price only when the scope is closed and known in advance.
At the start of the work I learn who is responsible for what, who makes the decisions and how work gets done today. I come with a quality management system I built, which already meets the regulatory requirements, and I adapt it to your needs and to the way you work. That way you do not start from a blank page.
I work with your team on what the company needs at that stage: the quality system, the technical file, regulatory submissions, risk management or PMS. I write documents, review what your team has written and explain what each authority requires. We meet regularly for updates, so nothing waits until the last minute.
If the project calls for an area outside my core expertise, I bring in another consultant. You approve them in advance, before they start working.
Before a regulatory submission, I go through the entire file and check that it is complete and consistent. Before a notified body audit or an FDA inspection, I prepare your team: what they will be asked, what to show and how to answer. If I built your quality system, or ran it as your quality manager, I do not perform its internal audit, so that the audit stays objective and independent. In that case I bring in an external auditor whom you approve in advance.
Every document I write belongs to you. I write it so that your team can run it without me.
Many clients keep working with me after the project ends. Usually it is a few hours a month, along with projects that change with what the company needs.
A first conversation
Looking at what you have
A clear proposal
Getting to know your people
The work itself
When more expertise is needed
Before the submission or the audit
It stays with you
Staying in touch
A 30-minute call. You tell me where you are, I tell you what I'd do first and whether I'm the right fit.