Results for “madr”

Creates and manages Architecture Decision Records using the Michael Nygard format, including new ADR creation, retrospective analysis, superseding, deprecating, and index generation.

Classify medical devices under EU MDR 2017/745, build technical documentation, plan clinical evaluations, and manage post-market surveillance and EUDAMED integration.

Classifies medical devices under EU MDR 2017/745 Annex VIII rules, including software per MDCG 2019-11, with examples and conformity assessment routes.

Create, extract, or convert architectural decision records (ADRs) using a structured template, with project context discovery and evidence-based review.