IVD & Lab Equipment Design:
Combining engineering expertise and industry experience
Bringing confidence and quality to your IVD product design
We partner with startups, SMEs and multinational companies in the IVD sector. Our experience includes developing rapid diagnostic devices, polymerase chain reaction (PCR) machines, and laboratory gas management systems.
We specialize in embedded systems and have in-depth knowledge of IVD software regulations and how to design to meet these standards.
IVD and medical devices are often complicated projects but our established process can bring clarity and efficiency to your project. Our electronics, firmware and mechanical engineers are accustomed to working with a larger team of biomedical engineers, as well as managing supplier and manufacturer relationships.
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 61010 - safety requirements for electrical equipment for measurement, control and laboratory use
IEC 62304 – medical software development lifecycle
If your IVD device includes embedded software, it’s important to understand the design process that’s outlined in IEC 62304. We’ve worked on numerous medical devices and IVD designs following these standards, which are required for regulatory compliance and reducing project risk.
Laboratory device design that meets regulatory requirements
Laboratory devices, though not as heavily regulated as IVD devices, still often face complex requirements and standards.
Laboratory products need to comply with IEC 61010 as well as other product-dependent standards. Our team regularly work to these standards and knows how to apply them to your product design.
For example, we may need to consider thermal management, the choice of material, and the mechanical endurance of the product for it to meet safety regulations and compliance.
Industry-sector experience and flexible support
One of the main advantages of working with an IVD product design company is that we have the processes in place to ensure your project runs smoothly. Device development can often be intermittent as prototypes are user-tested and funding rounds are secured. The flexible nature of our support means that you can call on us at any stage of your project.
Depending on your needs, we can support your team in designing compliant devices from scratch or guide your project as consultants.
We believe that successful projects are built on good communication. You can decide what type of meetings and communication work for your team and how often you want to meet. We can keep you informed of your project's progress by scheduling regular check-in meetings and providing detailed reports. Proactive feedback to ensure your lab device meets your exact specifications is always welcome.
‘’Adam, Christa and the team at Ripcord have provided an extremely professional and diligent service in assisting Accunea in the development of our IVD platform. Ripcord led the electronics and embedded software development of our complex medical device development. The project has been challenging and required liaising between multiple parties. The communication and time management has always been excellent, and Ripcord will continue to be a valued supplier to Accunea in the future.’’