Running a small machine shop and thinking about offering consulting to clients in medical device manufacturing. My lawyer says I can't call it 'engineering consulting' without a PE stamp, but I could do 'process optimization' or 'quality system guidance.' Has anyone navigated this? I'm not trying to become a regulator, just sell my expertise without tripping over licensing boards.
Compliance
How to consult in adjacent fields without compliance issues
Call it whatever you want but the minute you sign a report that says 'verified' or 'complies with 13485' you're the one holding the bag if it blows up. Your E&O carrier will care more about that language than the licensing board.
What state? Some states are way more aggressive about 'consulting' vs 'engineering' than others. In my experience the board only cares if someone complains, and that's usually a competitor who lost a bid.
lol 'just sell my expertise' is the most expensive sentence in small business
Three things I learned the hard way: 1. Never use the word 'certify' or 'guarantee' in a deliverable. 2. Have a scope-of-work document that explicitly says you are NOT providing design services or professional engineering opinions. 3. Make sure your GL and professional liability policies actually cover consulting, not just manufacturing. Most shop policies have a consulting exclusion. Also don't be surprised if the client's procurement department asks for a PE stamp anyway because their own SOP requires it — that's the fun part.
Is that really a compliance issue or are you overthinking? Plenty of retired shop owners do this and nobody comes after them.
Famous last words. The board doesn't chase you until a client's lawyer subpoenas your emails and finds you signed off on 'process validation.' Then suddenly it's a licensing question.
To be clear I'm not planning to do any design work. Purely advising on shop floor layout, tooling selection, and quality documentation. That's why I was confsued about the PE thing.
Shop floor layout is fine. Tooling selection starts to drift if you're recommending something specific for a regulated product. The line is blurrier than most people admit and it moves based on who's reading it.
This is going to sound annoying but get an actual healthcare/regulatory attorney for one consult, not just a general business lawyer. Mine caught a clause in my contract that would have made me liable for the client's recalls. Cost me $400 and saved me a mortgage.
$400 for a consult? My guy charges $600 just to return a phone call.
Different state, different pain. I once got told I couldn't use 'solutions architect' in a brochure. The board had nothing to do with it, it was some contractor's trade group.
Trade groups are worse than regulators honestly. They have a budget for letters.
Appreciate the warning. The recall clause thing is exactly what I worried about. I'll get the specialist consult before I take a single dollar.
Also worth checking the indemnification language before you you sign the NDA. Some clients bury mutual indemnity in there and somehow you end up insuring them.