Medical SPICE® || || ISO 62304

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

  •     software
  •     hardware
  •     and mechanics

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

ISO IEC 62304

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

  •     development time
  •     Costs and
  •     Quality as well
  •     Traceability == Traceability

across all domains, requires the right methods and tools
The list of standards in the medical field is long.

IEC 62366, ISO 14971, IEC 60601, ISO 13485 and Medical SPICE® (VDI 5702 - Part 1)

We are not in vain proud that our customers like with the statements

  • "Is the consultant company with the most experience - so I easily cancel the contract with the rekown xxx Innstitut" (Medical Startup) or
  • "You take over the construction of the entire Q and process world - with you it's hands on with results" (German University)

Our Kovair Templates

Our Kovair Templates

AUTOMOTIVE

ASPICE® and more

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

Aerospace

DO 178C and DO 254

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.

Medical Template

Standards realized

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

 

Project Management

ISO 16326

ISO 16326. "THE" standard for meaningful project management - and basically - very simple.

Organisation

ISO 9001 / Enterprise SPICE®

You can look at our template in a live demo - and of course the one we developed. Android APP.

 

Pharma

GAMP®

Overview of  GAMP®-Implementation as well as the main topics of ISO 14971, 21 CFR Part 11.