Results for “medical-device”
5 skills
alirezarezvani Mdr 745 Specialist
Classify medical devices under EU MDR 2017/745, build technical documentation, plan clinical evaluations, and manage post-market surveillance and EUDAMED integration.
20.4k · bundle
alirezarezvani Qms Audit Expert
Provides ISO 13485 internal audit methodology for medical device quality management systems, covering audit planning, execution, nonconformity classification, and external audit preparation.
20.4k · bundle
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tools-only 116 Mdr 27c00614
Classifies medical devices under EU MDR 2017/745 Annex VIII rules, including software per MDCG 2019-11, with examples and conformity assessment routes.
7 · bundle
k-dense-ai Iso 13485 Certification
Prepare ISO 13485:2016 certification documentation for medical device Quality Management Systems, including gap analysis, template-based document creation, and compliance checklists.
30.2k · bundle
dontbesilent2025 Dbs Report
Merges multiple diagnosis snapshots from dbs-save into a single, timestamped Markdown report organized by topic.