Choosing your regulatory monitoring
The medical device regulatory monitoring market has one thing in common: you rarely learn the price before talking to a salesperson. This page sets out what to look at before choosing, what we charge, and what we do not do.
The price almost nobody publishes
The leading international regulatory intelligence platforms do not publish their pricing. Some show tiers with no figures at all and point you to a quote; others have no pricing page and simply offer to book a demo. In practice you cannot compare without running several sales cycles, and you learn the order of magnitude weeks later.
Our pricing is on the site, with no form to fill in first. You can decide it is too expensive for you in ten seconds, which is the point.
Six criteria that make the difference
What the sources are, not how many
Does the link take you to the official text, or to an aggregator writing about it?
A catalogue of hundreds of sources says nothing about their quality. What matters in an audit is being able to open the text at the authority that published it. Ask to see ten real alerts and look at where the links point.
Evidence that holds up
Can you produce a timestamped report of what you monitored, and when?
ISO 13485 and the MDR do not require a tool, they require evidence. Monitoring that leaves no usable trail does not meet the obligation, however good its news feed is.
A price you know before you commit
Is the price public, or does it take a meeting to obtain?
Pricing on request is not merely inconvenient: it often means the figure depends on what the seller thinks you can pay. A published price commits the vendor to every customer in the same way.
Where your data lives
Is hosting European, and is the isolation verifiable?
Your monitoring scope describes your products and your markets, which is strategic information. Ask for the exact location of the database, not the vendor’s commercial region.
What the AI is allowed to do
Does it cite its sources, and does it say when it does not know?
A regulatory AI that invents a standard reference is more dangerous than useful, because the error is plausible. Test it on a question you know the answer to, then on one with no answer.
The case of consulting firms
Can you manage several client scopes under a single account?
A consultant following eight manufacturers should not need eight subscriptions or eight logins. That is a difference in how the product is built, not a pricing option.
What MedQara does not do
Better said before you waste time. MedQara is a monitoring and drafting-assistance tool. It is not a full regulatory management platform.
- No submission management and no country-by-country registration tracking.
- No UDI registration in official databases on your behalf.
- No lifecycle management for certificates and markings.
- No quality management system: MedQara feeds yours, it does not replace it.
If that is your need, RIM platforms are what you want, and they cost an entirely different order of magnitude.
Our pricing, plainly
Billed annually. A 30-day trial on the plan of your choice.
Frequently asked questions
How much does medical device regulatory monitoring software cost?
The market is wide and largely opaque: most international platforms quote on request only. MedQara publishes its pricing: €590 a year for an independent professional, €1,990 a year for a company, €3,900 a year for a firm following several clients.
Is regulatory monitoring mandatory?
The MDR and ISO 13485 do not mandate a tool, but they do require you to stay informed of the state of the art and the applicable regulation, and to be able to demonstrate it. It is the demonstration that fails audits, not the reading.
Can you do regulatory monitoring yourself, for free?
Yes, by subscribing to the authorities’ feeds. The real cost is not the subscription, it is the sorting time and above all building the evidence: a year later you must be able to show what was monitored and what came of it.
How do you check the quality of a monitoring service before subscribing?
Ask for ten recent real alerts and look at where the links lead: to the text published by the authority, or to an article about it. It is the fastest test, and it separates a lot of offers.