Results for “devices”
4 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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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
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