who my services are NOT right for

You need a full-time employee

I'm a consultant. If you need someone in-house, on-site, five days a week - this isn't the right model. If you need senior QA/RA expertise on a flexible, scalable basis, it is.

You want QA/RA on paper, not in practice

If the goal is to check a box for an investor deck or pass a single audit with no intention of maintaining the system - I'm not the right partner. I build real systems that hold up under scrutiny.

You want someone who will just tell you what you want to hear

My job is to tell you where you stand, what the risk is, and what needs to change. That's not always comfortable, but it's what protects you in an audit.

Your device involves sterilization or cleanroom manufacturing as a primary focus

I don't specialize in these areas and won't take on projects where they're central to the compliance scope. But I know excellent consultants that can help with that - so call me.

You need clinical evaluation or PMCF support

These are outside my scope. I work on QMS and regulatory compliance, not the clinical side of the technical file. But I know great people who do - so call me.

You need Economic Operator or Authorized Representative services

I don't serve as an Authorized Representative, Importer, or Distributor under EU MDR or other frameworks. These are legal entity obligations that require a registered presence, not a consulting engagement.