Work from verified requirements
The source page was originally published in 2019 and later included 2023 deadline updates. Its dates represent that evolving historical context. Device manufacturers should establish the applicable requirements for their products rather than treat an older article’s schedule as a current compliance determination.
Coordinate the delivery
Assess gaps, prioritize the affected portfolio, secure appropriate resources, and make dependencies visible across regulatory, quality, clinical, and technical teams. Experienced teams can apply lessons from one submission to the next. Strong program leadership supports progress and timely escalation, while practical external expertise can reduce unnecessary reinvention. Readiness is an integrated delivery challenge as well as a documentation task.