Tom Muller
Tom Muller has worked in medical device regulatory affairs for more than ten years. His work under the EU MDR covers ISO 13485 quality management, IEC 62304 software life cycles, IEC 62366 usability engineering and ISO 14971 risk management. In the US, he has led 510(k) submissions through to FDA clearance. He works as an independent regulatory consultant for medical device companies.
Tom has never worked for, consulted for or invested in any vendor reviewed on this site.
Why this site exists
A QMS is one of the first big software decisions a device company makes, and one of the hardest to undo. Yet most comparisons are written by the vendors themselves, prices are rarely published, and the big review platforms are paid by the vendors they list. Many of their reviews are invited by the vendor or rewarded with a gift card. bestqmssoftware.com compares the systems on the things that matter to a device company: what it costs, what the contract locks you into, and whether it covers ISO 13485, the EU MDR and FDA requirements.
How the reviews are made
Every review starts from public sources: vendor websites, published prices and contract terms, product documentation, company registries, review sites and user discussions. Each fact is recorded with its source and the date it was checked, and every score follows the same published rubric of twelve criteria. Reviews that haven’t been fully checked yet carry a notice saying so. How we rank explains the criteria and each score’s scale.
Independence
No vendor pays this site. There are no affiliate links, sponsored reviews or paid placements, and vendors can’t see or approve a review before it’s published. If that ever changes, How we rank will say so first.
Corrections and contact
If something is wrong, including if you’re a vendor, email [email protected] with a source. Confirmed errors get fixed, and the review’s “last checked” date is updated.