​
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.
