Evolution Engineering

Evolution Engineering is your end-to-end HF partner. We provide a variety of services to our clients to develop world-class medical devices and combination products. We can help with the following activities: • Human factors strategy ° Scoping HF activities and deliverables • Early-stage feasibility and planning ° UI landscaping ° Submission de-risking activities ° Detailed timeline • Formative studies ° Early-stage formative ° Use risk assessment updates ° Design improvement • IFU design & training videos ° IFU / user manual design ° High quality illustration drawing ° Rapid prototyping of instructions ° Training videos for clinical and commercial use • Summative studies ° Summative protocol compliant with FDA and IEC 62366 requirements ° Highly experienced study moderators ° Detailed root cause analysis ° Comprehensive residual risk analysis ° HF / UE summary report per FDA guidelines • Regulatory submission support ° HF regulatory strategy for US (FDA), EU (MDR) & Global ° HF pre-submission authoring ° FDA teleconference participation ° HF submission (e.g, 510(k)) authoring ° Notified body support for MDR • Lifecycle management activities ° Post launch activities ° Updates to design ° Documents / studies ° Complaints analysis ° CAPA