← Alle Begriffe
KATEGORIE: REGULATORY PATHWAYS
Gesamter Produktlebenszyklus (TPLC)
Der FDA-Ansatz, der alle Phasen eines Medizinprodukts von der Konzeption bis zur Entsorgung umfasst.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
Total product lifecycle (TPLC) is FDA’s framing that connects premarket review, manufacturing quality, and postmarket surveillance into one continuous safety/effectiveness story—especially visible in digital health and high-risk devices.
PROCESS / STEPS
- Plan premarket evidence with postmarket commitments in mind.
- Use real-world performance to refine risk controls and labeling.
- Feed complaints, MDRs, and recalls into design changes.
- Align cybersecurity and software updates with lifecycle risk management.
EXAMPLES
- AI device predetermined change control plans embody TPLC thinking for iterative model updates.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Gesamter Produktlebenszyklus (TPLC) across 27 authorities in real time.
START FREE →