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Insights on compliance
How to build your QMS without a €15,000 consultant (and when you genuinely need one)
Most of a startup QMS is learnable, structured work you can do yourself. Some of it genuinely is not. Here is the honest split, so you spend specialist money only where it earns its rate.
Read more →You built a health app in a weekend. The EU might call it a medical device.
AI coding tools mean anyone can ship a symptom checker or health tracker in days. Here is the line where your side project becomes a regulated medical device, and what to do if you have crossed it.
Read more →510(k), De Novo, and the US route for software startups, an honest primer
Selling software as a medical device in the US means the FDA, not a CE mark. Here is how the pathways differ, what changes with the QMSR, and how EU-first startups should sequence it.
Read more →From idea to CE mark, a realistic compliance timeline for software startups
Six milestones stand between your prototype and the EU market. Here is the founder's ladder, with honest durations for Class I and Class IIa software, and the one delay money cannot compress.
Read more →Do I need ISO 13485 before I can sell my product?
The question most medtech founders ask, answered honestly. Sometimes the law requires it, sometimes your customers do, and sometimes you can sell sooner than you think.
Read more →IEC 62304 for startups, what Class A actually requires (most guides get this wrong)
IEC 62304 is the software lifecycle standard for medical device software. Here is what Class A genuinely requires after Amendment 1, including the system testing obligation most summaries miss.
Read more →MasterControl pricing, and why startups keep searching for alternatives
MasterControl is genuinely enterprise software with genuinely enterprise pricing. Here is what buyers report, who it is actually for, and what to do if you are twenty years too early for it.
Read more →Greenlight Guru pricing, what startups actually pay in 2026
Greenlight Guru does not publish prices, and contracts commonly run one to two years. Here is what buyers report paying, what is included, and how to negotiate if it is the right fit for you.
Read more →Qualio pricing, what you'll actually pay in 2026
Qualio does not publish pricing. Based on publicly reported figures, here is what startups typically pay, what drives the number up, and the questions to ask before you sign an annual contract.
Read more →What ISO 13485 actually costs a software startup in 2026
Consultants quote €15,000+. Platforms hide pricing behind demos. Here is an honest, line-by-line breakdown of what ISO 13485 costs a small software team, and where you can legitimately spend less.
Read more →Local Enterprise Office grants: where Irish software founders start
Before the big Enterprise Ireland and EU programmes, there is your Local Enterprise Office. For early and micro software startups it is the most accessible non-dilutive funding in the country. Here is what is on offer and how to make your first ask a strong one.
Read more →EIC Accelerator and Horizon Europe funding for health software startups
The EU runs the largest innovation programme in the world, and the European Innovation Council Accelerator is its sharpest instrument for deep-tech startups. For the right medical software company it is transformative, non-dilutive money. Here is how it works and how to be ready for it.
Read more →Innovation Vouchers in Ireland: €10,000 of free expertise for software founders
The Innovation Voucher is one of the simplest pieces of non-dilutive funding in Ireland, and one of the most underused. A standard voucher is now worth €10,000 to buy in expert help on a business problem you cannot crack alone. Here is how it works and how a medical software founder can spend it well.
Read more →Enterprise Ireland funding for medtech startups: the HPSU feasibility grant
Enterprise Ireland backs ambitious, export-focused founders, and medtech and health software startups are exactly who they are looking for. Here is how the High Potential Start-Up feasibility grant works, what it funds, and how to walk in with a stronger application than most.
Read more →What class is your medical device software? Find out in two minutes
If you are building health software and someone asks what class it is, not knowing yet is completely normal. But your EU MDR class is the first thing you need to settle, because almost everything else depends on it. Here is how to find it in plain English with a free compliance tool built for startups, no guessing and no consultant required.
Read more →Do you need a regulatory consultant? What SaMD consulting really costs
Every founder building medical software gets told to hire a regulatory consultant. Sometimes you genuinely need one. Often you are paying consultant rates for work you could arrive with already done. Here is how to tell the difference and spend far less.
Read more →Grants for medtech and health software startups in Ireland and the EU
There is real, non-dilutive money available to early health and medical software startups in Ireland and across the EU. Here is a practical map of the main grants, who they are for, and what they fund, so you can put them to work early.
Read more →Why the world runs on the same standards for medical software
Founders assume every market has its own rulebook. For medical software, the foundation is the same everywhere -- the same three standards underpin the EU, the US, Canada, and Australia. Here is why, and what it means for what you build.
Read more →What an auditor actually looks for: the SaMD compliance checklist
Notified bodies and enterprise procurement teams ask for the same things. Here is a practical checklist of what you need to have in place before your first audit, and why each item matters.
Read more →SaMD compliance: a startup guide to FDA and EU MDR
Software as a Medical Device has different rules in the US and Europe, but the underlying compliance work is largely the same. Here is what you need to know before your first enterprise sale or regulatory submission.
Read more →When does software become a medical device in the EU?
If your app touches health data or clinical decisions, you have probably wondered this. The EU's answer comes down to one thing -- intended purpose.
Read more →AI and ML model compliance and what ISO/IEC 42001 means for your product
ISO/IEC 42001 is the new standard for AI management systems. If your product includes machine learning, here is what it asks for and how to get ahead of it.
Read more →Using AI for compliance is not cheating. It is exactly the point.
AI can generate requirements, suggest risk items, and structure your QMS from scratch. The standards allow it. Here is why AI-assisted compliance is legitimate, and what humans still need to do.
Read more →Compliance is not scary. Here is what it actually means.
"ISO 13485", "HIPAA", "IEC 62304" these words make founders nervous. They shouldn't. Compliance means following a set of rules and being able to prove it. Here is how it works.
Read more →A note from the founder: why I built QualiHQ
I was CTO of a diabetes AI company. Getting our QMS in place was one of the most frustrating experiences of my career. Not because compliance is hard, because the tools were terrible.
Read more →What is a QMS? A plain-English guide for software teams
No jargon, no consultants. Here is what a Quality Management System actually is, what the terminology means, and how SaaS teams use one.
Read more →The real cost of a QMS (and why most small companies can't afford it)
Greenlight Guru, Veeva, Qualio -- enterprise QMS platforms cost more than most startups can justify. Here is what a QMS should actually cost.
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