Medea Consul gets regulated products to market and builds the companies that carry them. Strategy first, then the quality system, the development, the audits and the filings. Twenty companies, five countries, certificates measured in months.
Companies supported
RheumaFinder
Agfa
Track record
The clock runs from the start of the engagement to the certificate. The companies are named. Ask any of them.
Services
I do not sell risk management by the hour, or clinical studies, or a template pack. I sell the decisions that determine whether your product reaches a market, and the company and process that get it there.
Which markets, in which order, on which claims, at which cost. Qualification and classification, the intended purpose your commercial story can actually survive, the evidence you will be asked for, and the sequence across Europe, the US and wherever you sell next. One document, written for a board rather than a filing cabinet.
DELIVERED AS A ROUTE MAP YOU CAN FUND AGAINST
Regulated development that does not slow your engineers down. Design controls, risk, software lifecycle, usability, security and verification handled as one process rather than six deliverables bolted on at the end. Whatever your product drags in — radiation, connectivity, AI, reprocessing — comes into the same system.
FROM CONCEPT THROUGH DESIGN TRANSFER
The quality system and everything around it: suppliers, manufacturing, distribution, servicing, the roles you are legally required to fill, and the organisation that has to run all of it on a Tuesday. I have built this twice from an empty room and now do it for others, standing in as PRRC, authorised representative or interim regulatory lead where that is faster than hiring.
QMS AND BEYOND
Internal audits, supplier audits, gap assessments and mock notified body inspections, run by a certified lead auditor who also sits on the other side of these conversations. The point is not a report. The point is that nothing in your certification audit is a surprise.
ISO 13485 AND ISO 27001 LEAD AUDITOR
Background
I have been in medical devices long enough that the experience is best measured in dog years. Two of those years were spent in Brussels while the MDR was being written — first for a trade federation, then for a manufacturer, arguing the same text from two different sides of the industry.
It teaches you something you cannot get from reading the final version. Where a rule is vague, I usually know why it is vague and what was traded away to get it there. Where the guidance is silent, I know whether that silence is an oversight or a decision. And where something is genuinely unsettled, I say so instead of inventing certainty, and we build around it.
Speaking
Keynotes, workshops and guest lectures on regulatory strategy, product development and what actually turns a product into a regulated one. English or Dutch.
Engagement & fees
Regulatory work lands at the worst possible moment for a young company's balance sheet. So the entry point is low, the fee rises only when you hit something worth celebrating, and for the right company I will take part of it in equity.
Fixed fee · 2–3 weeks
Monthly retainer · rolling
Low, deferred, or no cash fee
Clients
He flagged that our planned classification would not hold up, early enough that changing course was still cheap.
[Full name][Role] · [Company]
We had a quality system on paper that nobody used. What we have now is shorter, and the team actually follows it.
[Full name][Role] · [Company]
The deficiency letter came back with fourteen points. We closed it in one round.
[Full name][Role] · [Company]
He works like part of the team rather than an external adviser, and says when something is not worth doing.
[Full name][Role] · [Company]
Contact
Bring the product, the claim you want to make and the deadline. You leave the call knowing roughly what your route looks like, whether or not we work together.
This demo opens your mail client. On the live site, connect the form to your form handler.