Audits that show you where you stand
I run gap assessments, internal audits and supplier audits, prepare your team for notified body audits and FDA inspections, and support you on the audit days. I also carry out regulatory due diligence.
Three situations where this works best
A notified body audit, an FDA inspection or an MDSAP audit is on the calendar.
You want to know how the system looks to an outsider before an auditor sees it.
A critical supplier needs an audit, or an investor wants to understand a company's regulatory standing before a deal.
An audit is coming
You want an independent view
You are reviewing a supplier or a company
Your internal audit program is behind schedule.
Critical suppliers haven't been audited.
Your team has never been through an FDA inspection.
You need a gap assessment against a new standard or regulation.
You are investing in or buying a medical device company and need to understand its regulatory standing.
You probably need this if one of these sounds familiar
A clear picture before the auditor arrives
Where your system stands against ISO 13485, EU MDR, FDA QMSR or MDSAP.
Remote or on site, with a full report of findings and recommended follow-up.
A rehearsal with your team: what they will be asked, what to show and how to answer.
Preparation before the audit, and support during the audit itself.
Gap assessments
Internal and supplier audits
Mock FDA inspections
Support on the day
From a first conversation to the work itself
You tell me about the device, the market you are aiming for and your timelines. I tell you what I would do first.
When needed, I go through your procedures, your technical file or your most recent audit reports.
The scope of work, estimated hours and a timeline. I work by the hour.
I work with your team on what the company needs at that stage, and we meet regularly for updates.
A first conversation
Looking at what you have
A clear proposal
The work itself
A day before
7 days before
14 days before
30 days before
60 days before
90 days before
Tell me the type of audit and the date, and you will get a short email at the points you pick, each with what is worth doing at that stage.
Is an audit coming up?
Start my countdown
3 days after
Notified body audit (MDR or IVDR)
FDA inspection
I sent you an email. Confirm it, and the reminders will start.
Something went wrong. Please check the details and try again.
Almost done
MDSAP audit
The reminders are stopped. You will not get more emails about this audit.
The reminders start after you confirm the email I sent.
ISO 13485 certification audit
This year I ran many internal audits at the companies I work with, against the requirements of ISO 13485, the MDR and MDSAP. For one client, I also audited suppliers in Thailand and Japan. A company I've supported for several years has been through a number of notified body audits with me: I prepare the team, review the documents and go over the questions the auditors are likely to ask, and the audits have ended without findings.
A year full of audits
Notified body audits, FDA inspections, MDSAP audits and customer audits. I prepare your team, run internal and mock audits, and support you during the audit itself.
Yes, remote or on site, with a full report of findings and recommended follow-up.
No. If I built your quality system, or ran it as your quality manager, I don't run its internal audit, so the audit stays objective and independent. I bring in an external auditor you approve in advance.
What types of audits do you support?
Can you conduct supplier audits?
Can you audit a quality system you built for us?
Related articles
A 30-minute call. You tell me where you are, I tell you what I'd do first and whether I'm the right fit.