QUALITY SYSTEMS

One Pass to Production

We guarantee One Pass To Production™ for Printed Circuit Board (PCB) designs from initial concept, through to volume production of commercially-ready products, giving shorter time to market, and lower overall costs. This guarantee is unique among Australian electronics product developers. We can dramatically reduce product development cost while maximising quality. We guarantee that your first-pass electronics hardware will be fully functional, and avoid multiple prototyping iterations which other designers consider normal to get prototypes working, and even have built into their processes.

The Guarantee

"Where the printed circuit board assembly (PCBA) requirements do not change following circuit schematic sign-off, Genesys guarantees that PCBA prototypes meet their functional requirements, with no need for a second prototyping pass.

If a second prototyping pass is required due to our making a mistake, Genesys will make good the final PCB design at it's own expense."

 

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

Software Engineering

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.

Hardware Engineering

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 One Pass to Production guarantee 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.

 
 
Still need convincing that Genesys is simply the BEST electronics design firm in Australia?

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