From the test lab to your side of the counter.
The idea is simple: the device team should write its own case before anyone sells it evidence.
Built on work done at the test gate.
Joshua began at a medical device company as a manufacturing and supplier quality engineer, then manufacturing engineer. He moved into compliance engineering and went on to manage a compliance test lab that tested IT and medical equipment: electrical safety, EMC, usability and safety testing, packaged for FDA and notified-body submissions.
His work spans U.S. FDA, EU CE marking and other countries' requirements, which are "somewhat similar, but they do have a delta for each country."
Credentials and certifications: to be added.
Three rules we work by.
Write the case first
Scope goes to whoever writes it first. It should be the manufacturer.
A reason on every line
Including the standards that don't apply. “Doesn’t apply” is a decision, and decisions get written down.
Promise the work, not the verdict
We don't promise clearances, passes or smaller quotes. We promise the reasoning, on time.
Start with your device's case.
A 90-minute Roadmap Session and a one-page standards matrix you keep, whatever you decide next.