Product Design and Development
Design for Manufacture & Supply Chain Development
Regulatory Compliance for Medical Devices
Cormed - ROC Band
New product development of Radial Artery Optimal Compression Band, taking an initial design and developing it through CE & FDA approval and manufacture
The client was an established supplier to UK hospital cardiac catheter labs. User-insight highlighted a gap in the market of radial artery compression following radial access. ROC (Radial Optimal Compression) Band offers a unique feature regarding patent haemostasis to prevent permanent occlusion
The project had been started by another agency, so we took over and concluded the design process, helping the client build a supply chain and comply with regulatory requirements. This was the first time the client had developed their own product so we supported their engagement with key suppliers Rutland Plastics and Meridian Medical.
"Cormed needed an improved design and new prototype of a partially completed idea. Butters Innovation came to the rescue and not only created working models but worked with us to qualify for ISO:13485 and gaining a Class ll CE mark"
Chris Brown
Founder and CEO Cormed Ltd
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