Development Software as a Medical Device is not like creating a website or simple application.
ISO13485:2016
We work to ISO13485, and whether you are medical device manufacturer or not this will provide assurance that our processes are robust and externally accredited to ensure the quality of our output now, and as we support it on an ongoing basis.
IEC62304 and 82304
We follow rigorous software development lifecycles compliant to international standards, and expect our clients to demand documentation to support their own regulatory journeys.
