Use Case
Post-market device change and lifecycle management
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A marketed combination product experiences a supplier, material, manufacturing, or automation change requiring evaluation for regulatory, usability, and biological safety impact.
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Determining scope of downstream impact
Evaluating need for bridging activities
Assessing risk documentation updates
Understanding impact on usability and patient interaction
Managing supplier and documentation coordination
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ToxStrategies — Material and toxicological impact evaluation, E&L reassessment support, biological safety risk review
Design Science — Usability impact assessment, labeling and training implications review, determination of potential HF validation impacts
Suttons Creek — Change impact assessment across design, risk, and regulatory files, bridging strategy and reporting category determination (CBE-30, PAS, Notified Body notification), DDF and risk file updates
Modality Solutions — Transportation and packaging reassessment support where distribution conditions may be affected
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A more structured and risk-informed approach to evaluating post-market changes and determining appropriate downstream actions.