Project Management
Suma Medtec’s project management expertise will keep you on track, acknowledge risk, resolve barriers, and enable a team that achieves to the beat of a winning culture.
Align
Strategy alignment is important to achieving project milestones. We seek endorsement with internal and third-party stakeholders, or facilitate communication with regulatory authorities.
Plan
We prepare and execute on each stage of development: Design Inputs, Outputs, Verification, Validation, Transfer, Global Submissions, Launch.
Document
A complete Design History File is paramount to subsequent submission and commercial activity. We ensure adherence to FDA 21 CFR 820, EU MDR, and other applicable regulations.
Prepare
Timeline, budget, and resources - these are just a start. We implement a risk and contingency plan to maintain momentum even under unexpected circumstances.
