Update on ISO 13485 and IEC 62304
As part of our ‘IEC 62304 ready’ software libraries initiative, we have now broadened out to a fully library-based ISO 13485 compliant development process, based on mature and traceable pre-compliant design templates developed under Genesys’ stringent quality system.
This enables us to offer simple and cost-effective development of medical device electronics and software without compromising our high-quality standards.
We are talking about more than just document templates. We have a fully traceable, fully systematised structure which integrates hardware modules, software modules, risk management, requirements traceability and design traceability.
This is the only approach to take to development where, as a customer, you want to pay for the application development and not the platform development, and you want to pay for features and not bugs or wheel re-invention. And of course, you want meaningful and useful documentation which meets regulatory and standards obligations, without paying through the nose for document writing.