The people behind
your compliance peace of mind
We're a team of engineers, quality experts, and compliance nerds who believe medical device companies should
spend their time building products that save lives - not reconciling spreadsheets before every audit.
Medical device companies exist to build products that save lives.
But too often, brilliant engineering teams are buried under compliance overhead - chasing paper trails, reconciling spreadsheets, and scrambling before every audit.
We started Orcanos because we saw
firsthand how disconnected tools
cost teams months of productivity
and created real risk.
Our answer: one adaptive platform
where quality management and
product development share a single
source of truth - so compliance
accelerates your roadmap instead of
blocking it.
Today, over 100 medical device
companies - from pre-market
startups to global leaders like GE
HealthCare - trust Orcanos to keep
them audit-ready, every single day.
Two founders, one gap
nobody else would fix
Orcanos started with two founders, Rami Azulay and Zohar Peretz,
who kept running into the same problem at medical device
companies: Quality and R&D speaking two different languages,
working in different tools, and reconciling their records by hand in
the two weeks before every audit.
That reconciliation is where products get delayed, where audit
findings come from, and where good people burn out. It isn't a
training problem or a discipline problem - it's an architecture
problem. The software R&D uses and the software Quality uses
were never built to know about each other.
Rather than raise money and chase a broad horizontal market,
Rami and Zohar bootstrapped Orcanos to solve one problem well:
give medical device companies a single connected record of
quality and engineering truth. No outside funding - just two
people who'd seen the gap firsthand and decided to build the fix
themselves.
From a two-person bet to the platform
100+ MedTech companies rely on.
Relaunched our platform, marking the moment QMS
and ALM became a single, fully unified solution.
Crossed 50 MedTech customers across North America,
Europe, and Asia-Pacific. Added supplier qualification
and engineering change order modules.
Launched Ask Paul, our AI assistant for compliance. Surpassed 100 customers. Named G2 High Performer, Fastest Implementation, and Best ROI.
Continuing to expand the unified eQMS + ALM platform
with deeper AI capabilities, broader regulatory
coverage, and the same fast go-live promise.
What we actually do differently
We don't say it unless we
can prove it. If we can't
point to the number, the
customer, or the exact
workflow behind a claim,
we don't make
the claim.
Your process isn't a bug
we're going to fix.
The teams who succeed
already know their process.
Software should adapt
to that, not override it.
We'd rather lose a deal to
honesty than win one with
a demo that oversells what
the platform does on day
one.
We measure ourselves
by what happens when
the auditor walks in
unannounced - not by
what shipped this
quarter.
Who we serve
Quality and Regulatory leaders
You own the audit outcome and the CAPA backlog, and you're the one standing in the room when the inspector asks a question nobody prepared for. Orcanos was built so that room stops being a surprise.
.png)
R&D and Engineering leaders
You're the one re-explaining a design
decision to a compliance tool that doesn't
already know it. Orcanos was built so that
stops being your job.
.png)
Executives and founders
You're the one whose runway or reputation
is riding on whether the company you built
can prove, on demand, that it's exactly what
it says it is. Orcanos was built so that's
never a scramble.
What our customers say
In a week and a half, I had four days of auditing. No back room, no binders, no scrambling. Everything was handled directly inside Orcanos.
We obtained both CE certification and FDA clearance with Orcanos. The attention and expertise in the medical device industry made this the right choice for ZygoFix.
Orcanos provided the optimal solution for documenting and distributing requirements. As a startup, their attention helped us transition smoothly into the digital world.
Ready to see what compliance without compromise looks like?
Join 100+ medical device companies that chose Orcanos to unify quality and
engineering on one platform.