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Medical Device Design

Partners

Helping industry frontrunners stay ahead of the curve.

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 over 10 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.

Our Electronics Capabilities are Untouchable

In today’s rapidly evolving technological landscape, timing is everything. That’s why we prioritise efficiency, helping you save time and money to accelerate operational growth.

Quality Management

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.

Risk Management

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.

Electronics Design

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.

Software Development

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.

Industrial Design

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.

Verification

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.

Production

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.

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