immediate relief from IVDR induced headaches
software built for
regulatory compliance
free 30 min evaluation with kevin
free 30 min evaluation with kevin
we know the clinic
user of our systems
how is your journey to IVDR compliance?
on a road to nowhere
DOCUMENT CONTROL
drowning in paper work?
Do you have a system for documenting work done, decisons made and approvals given. Are you able to track changes, log who made them and then revert to a previous version?
tracing/reporting
birds eaten your breadcrumbs?
Have you implemented a system where you can track back through all your disjoint decisions, processes and documents. Are you able to generate reports about your systems current state, work that took place and who performed it?
process/workflows
flooded workflows?
Have you selected a workflow engine, what about designing and implementing your processes. Are you able to generate tickets and track the movement of work through your processes
change control + communication
lost your message?
Can your system approve and communicate decisions, changes and results to the appropriate stakeholders. Are you able to acknowledg your message has been recieved by intended recipient?
hang on tight...
help is on the way
custom software solutions compliant with IVDR
consulting +
auditing
expert consulting
whatever your question in regards to software regulatory compliance, we can answer.
system health check
let us audit any aspect of your quality system, we can assess and show you how to fill your gaps
fractional assignment
don't burden yourself with a full time employee, bring us onboard as a fractional, save time and money
solution architecture +
design
device design
we will listen to your problem, convert them into design requirements and give you and architectural solution ready to implement
proof of concept
we will build a minimum viable product version of your device, from here you can iterate fast and change for the better
software development +
implementation
device development
developing software as a medical device takes the best engineering practices and applies them in an efficient manner
validation + performance
process validation, analyte validation and clinical validation are used to measure a devices performance and quality
implementation
deploying a device into a production environment and ensuring it is performing as intended for the end user
dev ops
programatic software delivery and configuration management ensure a more reliable and safer device
our scientists and engineers are regulatory experts
they've built and submitted regulated devices around the globe
United States
Europe
Japan
ready to say goodbye to your IVDR headaches?
