we simplify
market access

for digital health and medical devices

Regulation

Cyber

development

SQA

It can be complicated

expensive and time-consuming to develop and certify software medical devices on your own.
Our solutions solve this problem by providing you with compliance staff so that your company and product meet the increasing development & regulatory demands fast and hassle-free.
With our Partnership Approach, we work together to understand your project parameters properly.

We simplify

and speed up the software development and regulatory certification of your medical product.

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our Customers

IEC 62304:2015 Software Life Cycle Processes

Idea
Planning
Specification
Design & prototype
Software Development
Testing
Deployment
Operation & maintenance
WHAT OUR CLIENTS SAY
WHAT OUR CLIENTS SAY