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.

Plan: We prepare and execute on each stage of development: Design Inputs, Outputs, Verification, Validation, Transfer, Global Submissions, Launch.

Prepare: Timeline, budget, and resources -  these are just a start. We implement a risk and contingency plan to maintain momentum even under unexpected circumstances.

Align: Strategy alignment is important to achieving project milestones. We  seek endorsement with internal and third-party stakeholders, or facilitate communication with regulatory authorities.

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.