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Patient-matched cutting guides for Total Knee Replacement
Single-use cutting guides designed specifically for each individual patient using scan data and a surgeon-approved pre-operative plan. The nylon instruments are 3D printed using Selective Laser Sintering (SLS) and sterilised by gamma irradiation.
our role...
- project management of the development of the guides, supply process route and pre-operative planning software;
- user requirements for the software and online Case Management System (CMS);
- dFMEA and pFMEA for the guides, software and supply route;
- software validation and user test plans;
- liaising between the Manufacturer (our client), software developers and SLS and clean-packing suppliers;
- working within the client’s QMS to complete technical documentation for CE marking
Product images and Planner screenshots by permission, Design Rights MatOrtho Ltd.