The best way to find out if your business would pass a medical device inspection is to run it on yourself first. You don't need a consultant: you need 30 minutes and some honesty. Here are the six questions, in roughly the order they tend to come up, with timing.
Minutes 0-10: product paperwork
1. CE mark and declaration. Pick three products at random from your shelves or storeroom. Can you locate the evidence that their CE mark and declaration of conformity were checked? Not "I know the manufacturer has it" — find it yourself, right now. 2. Labelling and instructions in the required language. Do all three products meet that? Is there a record that you checked it when they arrived?
Minutes 10-20: live records
3. Complaints log. Does it exist, even if it's empty? Having it in place IS the obligation; an inspector can tell the difference perfectly well between "no complaints" and "no log." 4. Non-conforming products. What did you do with the last defective or recalled product? Was it written down?
Minutes 20-30: traceability
5. Who you buy from. Supplier records with their certificates — and do you know which one expires soonest? 6. Who you sell to (with batch number, where that applies). If a manufacturer recalls a batch tomorrow, how long would it take you to find out whether you have it, or ever did?
Score each question: green (I can show it right now), amber (it exists but would take a while), red (it doesn't exist). Two reds or more and you've got homework to do — better to do it now than have an inspection report point it out for you. Dossalis's mock-inspection mode runs through exactly this exercise on your real data and leaves you with a list of what's missing — and the inspection kit turns the greens into a stamped PDF, ready for the real visit.
Would you pass an inspection today?
Take the inspector's test: the 6 real questions, 2 minutes, instant result. Nobody else sees your answers.
Take the free testQuick questions
Who inspects medical devices at a business premises?
Regional health authorities (with AEMPS at national level). How closely they check varies by region, but the obligations under article 14 are the same across the whole EU.
How often should you repeat the mock inspection?
Quarterly is a good rhythm, plus any time you change supplier or add a new product category. With the dashboard, the mock inspection takes 10 minutes because the data is already in there.