Contact MD Regulatory
Questions about a kit, support with an order, or a consulting brief. Every message is read and answered by a regulatory professional — not a ticket queue.
Typical reply within one business day, Monday to FridayKit & order support
Download link not received, invoice with your VAT number, file format questions, or anything about an order you've already placed.
Email usWhich kit do I need?
Tell us your device, its classification and your target market. We'll tell you which kit covers it — and which doesn't.
Ask before you buyConsulting & PRRC
Technical File authoring, gap analysis, Notified Body remediation, PRRC services, audit preparation.
Start a briefSend us a message
The more you tell us about your device, the more useful the first reply will be.
What happens next
A reply, not a funnel
We read it properly
Your message goes to a regulatory professional with 15+ years in medical device compliance, including as a Notified Body auditor and ISO 13485 Lead Auditor.
You get a straight answer
If a kit solves your problem, we'll say which one. If it doesn't, we'll say that too — and tell you what would.
No sales sequence
Contacting us doesn't put you on a mailing list. You'll hear back once, from a person, about the thing you asked.
Before you write
These five come up most often. If your question is here, you already have the answer.
I bought a kit but didn't receive the download link.
Check your spam folder first — the email arrives within a few minutes of payment. If it isn't there, write to info@mdregulatory.com with the email address used at checkout and we'll resend it.
Can I get an invoice with my company VAT number?
Yes. Send your order number and full billing details (company name, address, VAT number) to info@mdregulatory.com.
What format are the documents in, and can I edit them?
All documents are fully editable Word and Excel files. No locked PDFs, no watermarks. They are templates you complete with your own device data — not a substitute for regulatory judgement.
Will a kit make my device compliant?
No. A kit gives you the structure, content and cross-references a Notified Body expects to see. The device-specific evidence, and responsibility for it, remain yours.
Can you review my Technical File before submission?
Yes — that's a consulting engagement. Write to info@mdregulatory.com with your device class, target market and timeline.
Company details
Business
MD Regulatory — Alessandro Stella
Milan, Italy
VAT / P.IVA: IT12319920964
Contact
Working hours
Monday – Friday, 09:00 – 18:00 CET
Written enquiries only. We don't take unscheduled calls; if a call is needed, we'll propose a slot.
Based in Milan, Italy. Working with manufacturers across the EU, UK, US, LATAM, MENA and APAC. · LinkedIn