Medical Device Design & Development:
Where experience meets innovation
Supporting companies to develop safe, reliable and compliant medical devices
Developing medical products and devices in a heavily regulated industry requires engineering expertise and first-hand sector experience.
For companies that need additional capabilities, or increased bandwidth, we can become involved in your project at any stage, providing end-to-end design, or standalone support.
We’ve partnered with well-funded startups, established SMEs and multinational healthcare companies, to develop organ preservation devices, drug delivery devices, physiological wearable devices, real-time biosensing technology and rapid diagnostic devices. We therefore understand the nuances of medical regulations and how they apply to electronic devices.
Reliable, safe, compliant
medical device design
As experienced medical device design engineers and specialists in embedded software, we’re trusted by healthcare companies to develop products that are compliant with industry standards.
Our team regularly works to the following standards:
ISO 13485 – the Quality Management System (QMS) for medical device development
ISO 14971 – the risk management process used in medical device development
IEC 60601 - safety and performance requirements for medical electrical equipment
IEC 62304 – medical software development lifecycle
Understanding the design process that’s outlined in IEC 62304 is essential to developing embedded software for medical equipment. We’ve worked on numerous medical device designs following these standards, which will save you time, money, and stress in the long run.
Your partner in medical device development
As a medical device design consultancy, we understand the unique challenges of the medical sector. We will work with you to develop your device functionality in a way that satisfies your user and regulatory requirements.
We can serve as technical consultants to advise your team or manage your entire medical device electronics and software design process, allowing you to concentrate on other aspects of your business.
Progress updates are provided every step of the way, with scheduled check-ins, detailed reports, and proactive feedback to ensure your medical products work exactly as they should.
“ ... we’ve discovered that Ripcord Designs add a fresh perspective, challenging accepted thinking while offering fresh ideas and insights to the design process. They have a great team of specialists who are knowledgeable, responsive and pragmatic. ”
