ISO 13485 Medical Grade Quality
ISO 13485 is one of the most rigorous quality standards in the world. It has to be, as it covers the development of medical devices that can influence the safety, diagnosis and treatment of a patient's conditions. Medical devices need to be completely safe from both an electrical viewpoint and by performing accurately, exactly as designed.
Genesys is certified to ISO 13485 and applies the same standard of quality to every project, regardless of what industry you are in. We can do this cost efficiently, because we have fully integrated the quality control processes into our engineering design processes – it is not an add on.
Our medical grade quality system is suitable for any device that has a requirement for absolute reliability. This includes any device that is part of a mission-critical or safety-critical system, and for products where failure in the field is unacceptable, from a brand and maintenance perspective.
Our Design Methodology
Genesys uses formal software engineering methods for all its firmware and software, in accordance with rigorous procedures for architectural design, modularity, coding standards and verification at the software unit and system levels.
Our code is designed using a highly modularised approach. Each module is rigorously tested to ensure that it is reliable and bug-free. New applications can re-use these modules, which greatly reduces the amount of new code required.
We also develop all our code according to the IEC 62304 standard for development of Medical Devices Software. A key feature of this standard is design control. You have to be able to trace user requirements and ensure that the device delivers the essential performance that was intended. This requires robust documentation and design review systems.
All these methods set Genesys' software engineers apart from "programmers" who often do not have formal software engineering qualifications. By contrast our code is robust, reliable, well documented, easily maintainable and scalable.
Genesys has extended its modular approach to its hardware designs. The Genesys Modular Stack is a set of common electronics functions which are fully integated with companion software modules. The modular electronics designs can can be implemented on separate stackable boards, as illustrated, or designed into custom boards.
We also develop all hardware under a proven methodology with multiple review points, allowing us to easily achieve compliance with the most rigorous standards, including IEC 60601-1 for Medical Electrical Equipment; and similar standards for other domains. Key features of these standards include specification, review and design verification testing, which we undertake for all of our designs.
A Culture of Excellence
Our reliability is enabled by our culture of excellence. We express this culture through a number of pillars, including:
understanding what our customers are asking for
deep domain expertise in electronics and software technologies
in-depth knowledge of technical standards and compliance regimes
acquisition and development of the most skilled personnel in the market
creation and application of the most effective engineering processes possible
maintaining the rigour and integrity of our design review processes
The culture is underpinned and modeled by the directors of the company who, together, have over fifty years of experience.
Our Strategic Quality Triangle
Genesys recognises that the quality of the final product is only as good as the companies we partner with in delivering a complete product design process.
We have chosen strategic partners for industrial design and electronics manufacturing, which both have ISO 13485 medical device quality certification.
If you are developing medical technology, having approved suppliers certified to ISO 13485 greatly simplifies your approval processes and may remove your obligation to do a full audit of the supplier.