We’re independent
No vendor pays us. We don’t take money for placements, don’t use affiliate links, and don’t accept sponsored reviews. Vendors can’t see or approve a review before it’s published.
If that ever changes, this page will say so first, and every paid link will be labeled where it appears.
How the overall score works
Each system gets a score out of 10: the average of twelve criteria, which all count equally. Each criterion is scored from 0 to 10 using a written rubric, so two reviewers looking at the same evidence reach the same number.
| Criterion | What we look at |
|---|---|
| Compliance coverage | How much of ISO 13485, FDA QMSR, Part 11 and EU MDR the system covers, clause by clause, plus validation documentation and security certifications. |
| Design controls and traceability | Requirements, risk (ISO 14971), verification and software lifecycle (IEC 62304) linked end to end, and whether the design history file is generated for you. |
| Usability | Ease-of-use ratings from review sites, and what users say about day-to-day work. |
| Support and onboarding | Support ratings, and whether onboarding help is included in the price. |
| Community sentiment | Overall ratings and what people say in communities like Reddit and LinkedIn. We leave out posts by vendors and their competitors. |
| Affordability | Estimated yearly cost for a 10-person team, including required setup fees. |
| Price transparency | Whether you can see prices before talking to sales. |
| Try before you buy | Whether you can try the product yourself, or only watch a sales demo. |
| Contract and lock-in | Minimum contract length, whether you can take all your records with you when you leave (and whether that costs extra), and whether you get your data back if the vendor closes or is sold. |
| Time to go live | How long it usually takes until your team can work in the system, and whether templates are included. |
| EU data residency | Whether your data can be hosted in the EU, which matters for many EU MDR companies. |
| Budget predictability | Whether you can predict next year’s bill: price-increase clauses in the contract, the vendor’s price history, how costs grow as you add users, and whether existing customers report surprise increases. |
We base scores on vendor documentation, published and archived pricing, review sites, and what users say in public communities. Claims on a vendor’s marketing pages alone don’t count as full support; we look for documentation of how the feature actually works. Each review lists its sources.
How each criterion is scored
Every criterion is scored from 0 to 10 using the same rules for every vendor. These are the rules in plain language; the full rubric is longer, but nothing in it contradicts what’s here.
Compliance coverage
We check 17 requirements from ISO 13485, FDA rules, Part 11 and EU MDR (the clause matrix on each review). A requirement only counts as fully supported when the vendor’s documentation, a demo or an independent source shows how the workflow works; a marketing page that just names it counts as partial. Compliance coverage is mostly the share of the 14 quality-process requirements a system covers, plus half a point each for a validation package and for an ISO 27001 or SOC 2 Type II certification.
Design controls and traceability
Based on the design and development, risk management (ISO 14971) and software lifecycle (IEC 62304) rows, plus a point each for documented end-to-end traceability, integrations with engineering tools like Jira or GitHub, and automatically generated design history files or trace matrices.
Usability
Starts from the ease-of-use rating on the review site where the product has the most reviews (G2 or Capterra, at least 10 reviews). One point up or down when at least three independent users report the same thing, and the opposite view isn’t twice as common. No usable rating means 5.
Support and onboarding
Starts from the support rating on the same review site, plus a point if onboarding help is included in the price, minus a point for a recurring support complaint.
Community sentiment
Starts from the overall review-site rating, adjusted by a point when independent users in communities like Reddit are clearly positive or clearly negative. Posts by vendor staff and competitors don’t count. If there’s documented evidence of organised review campaigns, usability, support and sentiment are capped at 8.
Affordability
Estimated yearly cost for a 10-person team, including required setup fees: 10 for up to $5k, 8.5 for $5k–10k, 7 for $10k–20k, 5.5 for $20k–35k, 4 for $35k–60k, 2.5 above that.
Price transparency
10 for a full public price list on the vendor’s own website, 8 if some plans have public prices, 6 for a starting price only, 3 if prices were published in the past, 1 for “contact sales” only. Prices the vendor gives to third-party directories don’t count.
Try before you buy
10 for a free trial or free plan you can start yourself, 7 for a trial after a short sales call, 5 for a product tour plus a live demo, 3 for a live demo only.
Contract and lock-in
Starts from the minimum contract term (monthly 10, annual 8, two years 6, three years or more 4). Points come off if there’s no documented way to export all your records, no public API, or reported lock-in problems. Charging a fee to get your complete data out at the end of the contract costs 3 points. A guarantee that you get your data back if the vendor closes or is sold adds a point.
Time to go live
From 10 for up to two weeks to 2 for more than six months, plus a point if ready-to-use SOP templates are included.
EU data residency
10 for EU hosting on all plans with a public data processing agreement and subprocessor list, down to 2 when there’s no public information on where your data is hosted.
Budget predictability
Starts at 10 if current prices are public, 7 if only the contract terms are, 5 if neither. Points come off for uncapped price increases in the contract, list-price rises of more than 10% in the last three years, repeated user reports of renewal hikes, and a cost per user that rises as you add users.
The company behind each product
Each review has a short, factual section on the company: who owns it, when it was founded, funding and acquisitions, and figures from public filings such as company registers. It isn’t part of the score. It’s there so you can judge for yourself how likely a vendor is to be sold or change direction. We don’t repeat rumours or speculate.
How the homepage ranking adapts to you
The sentence at the top of the homepage doesn’t change any vendor’s score. Each system also gets a fit rating for each answer: how well it suits a team of that size, that product type and that regulatory goal. Your answers pick which fit ratings count, and the list is sorted by the combined fit. Ties go to the higher overall score.
The clause matrix
For each ISO 13485 clause and related standard in our comparison tables, we mark whether a system supports it out of the box, partially or through a paid add-on, or not at all. When we couldn’t find evidence either way, we say so instead of guessing. We assess what a device company would buy for full QMS coverage, not custom configurations.
Keeping it current
Every review shows the date we last checked it. We re-check each system at least twice a year and after major releases, and update scores when the product changes.
Corrections
If you spot something wrong, including if you’re a vendor, email [email protected] with a source. We’ll check it and fix confirmed errors.