Experience Makes the Difference
It takes more than just great ideas and passion to create a successful product. Experience makes a world of difference. With 9 years of operation under our belt, Ingenuity’s multidisciplinary team is equipped with the specialised insight needed to develop medical devices for the real world.
We engage in all aspects of product development, including software, electronics, mechanical and industrial design. Our scope of work extends from concept to prototyping, to certification and manufacturing support. We have mastered the balance between engineering, commercial and clinical requirements, leading to award-winning products.
Professional Medical Device Development
Ingenuity provides a comprehensive product development service through an extensive skillset and experience in developing medical devices to meet compliance requirements. We are a trusted partner, empowering our clients to overcome hurdles and guiding them through the medical device development process.
Ingenuity’s quality management system (QMS) is certified to ISO 13485. We can work with clients’ existing QMS or can help set one up for electronics and software. . Our team are also experts in producing a DHF and DMRs that can go straight into a tech file.
Managing risks well is the key to developing safe medical devices. The Ingenuity team can assist clients to produce a hazards analysis that meets the ISO 14971 requirements.
The Ingenuity team engages in all aspects of analogue and digital circuit design including simulation, schematic capture, PCB layout and prototyping. Our team are also experts in laying out complex, multilayer, high-speed circuit boards. We love a challenge, and are skilled in pushing design constrains to fulfil briefs while meeting IEC 60601-1.
Our dedicated software team are sophisticated problem solvers. They do everything from developing apps and servers, to complex Linux embedded systems – all while complying with IEC 62304.
Ingenuity takes pride in designing products that people love to use, and that are are validated as usable to the IEC 62366 standard. In designing products for the medical environment, we take care to ensure products are biocompatible and can be effectively cleaned.
The traceability of each verification test is vital to the development of high-quality medical devices. At Ingenuity, we conduct inhouse verification of designs against the product specification.
Regulatory and Certification Support
We know how to develop designs to meet stringent compliance requirements, such as electrical safety, intrinsic safety and medical device standards. We handle all aspects of the compliance process, including compliance planning, risk analysis, FMEA and managing certification labs.
Understanding the manufacturing process enables us to design products for high volume manufacturing. We develop product test systems including automated test jigs, that maximise manufacturing yields and through put. Ingenuity also has ISO 13485 approved partners in Australia and internationally, and our DMRs are suitable for any manufacturer.
Award winning capabilities
We’re passionate about good design. It’s nice that others appreciate our design work too.
With over 35 awards under our belt, Ingenuity is renowned for creating innovative products that humans love.
Oh, we’re certified
We set our own standards, but it’s good to know we’re also certified to:
Ingenuity’s quality culture permeates everything we do. Our quality processes and systems are second to none and ensure high-quality products.
Our work speaks for itself
At the core of Ingenuity is our passion for innovation and the development of exciting new electronic products which improve our world. Drawing on a wealth of knowledge and skill built from years of experience, we’ve successfully brought hundreds of diverse products to life. Here’s a glance at what we’ve been working on.
THE MOST CREATIVE TEAM
Why work with us?
At Ingenuity, we design products that are commercially ready and are optimized for use in the real world.
Award winning design
Our products are cleverly designed, innovative and a pleasure to use. That’s why we have 35 awards under our belt.
Capabilities & experience
With 10 years of experience in developing hundreds of diverse products, we have the knowledge and skills needed to make extraordinary products a reality.
Quality, culture, & processes
Ingenuity’s quality culture permeates everything we do. Our quality processes and systems are second to none, ensuring high-quality products.