ISO 62304 still has priority, but the VDI 5702 Medical SPICE® is already available.
But SPICE® is not just a "software topic"
SPICE affects the entire organization. And - there is a model, too
The life of the patient will later on rely on a correct development of the whole system, working
Regulatory requirements are strict - often because quality (compliance with requirements) - is not the main focus of the companies.
Along with the demanded technical good solution are processes, methods according to
In combination with good project management, for example: according to
ISO / IEC / IEEE 16326: 2009 Systems and software engineering - Life cycle processes - Project management
Control of development in terms of
across all domains, requires the right methods and tools
The list of standards in the medical field is long.
We are not in vain proud that our customers like with the statements
Our template may be a little big, but in a few simple steps - by simply fading out the things you do not need - you and your team are "ready to go"
Suitable for ASPICE®, ISO 26262 and VDA 6.3 development.
Includes 20 "standard" plans as templates. -> Ready to go
Software and hardware development for aviation.
Unimaginably uncommon for the "normal citizen" - rather relaxed for the professionals in the environment.
Of course we help you with the qualification according to DO330.
ISO 13384, 14971, 60601 ... our medical solution has it all.
As with all other templates, we tend to create "150%" templates.
Cutting off is always easy- Ask us for a Life Demo