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


Evolution Engineering

Org chart

Teams

Offices

Evolution Engineering

Org chart

Teams

Offices

Related companies