focus on your science: leave the regulatory to us

we can build/help you build, safe, high quality performing diagnostic devices

Dx Lab

want keep your in-house assay on market post IVDR transition

regulatory compliance
gain competitive advantage
keep assay on market

Startup

commercialising a novel assay to be used in a regulated market

increase valuation
shorten development
accelerate using quality

Pharma

looking to build a companion diagnostic for your latest therapy

speed up approval
focus on core business
keep assay on-market

Diagnostic Laboratory

are you a health institution and IVDR exempt as per article 5(5) of (EU) 2017/746

want keep your in-house assay on market post IVDR transition?

general safety and performance requirements are still applicable

Startup

are you developing a novel assay that will be used in a regulated market

is regulation slowing down your ablity to get to market fast

use our gated pathway to get your assay compliant and increase your valuation

Pharma

do you have specific biomarkers to which you need a companion diagnostic

do you want to keep your therapy on market post IVDR

the larger and more complex a company, the harder it is to gain regulatory approval

our scientists and engineers are regulatory experts

we've built and submitted regulated devices around the globe

EUROPE

PDMA

USA

PDMA

JAPAN

PDMA

Software across the world

we know the clinical laboratory

users of karilian software solutions

How we can help you

our 3 steps to meet regulatory compliance

1 setup your lab for device creation

select, implement and integrate your software and hardware into a working regulatory stack

2 build, launch + monitor your compliant device

create and implement the processes, documentation and traceability required to build and maintain your device

3 validate your compliant devices

test and meaure the analytical and clinical performance of your device to detect a given biomarker

karilian

compliant molecular diagnostic devices on market faster

Dx Lab

person pictogram

get your in-house assays compliant

Startup

use quality to accelerate your evaluation

Pharma

money pictogram

make your own CDx + keep your therapies on-market