🇪🇺 European edition - content reframed for EU MDR, MDCG 2019-16 and notified bodies. US/FDA edition →Serving EU MedTech remotely from US HQ - EU contact: [email protected]
EU MDR Postmarket Cybersecurity
What's included
- Vulnerability handling SOP (ISO/IEC 30111)
- Coordinated disclosure policy (ISO/IEC 29147)
- SBOM monitoring and VEX update workflow
- PSUR cybersecurity input templates
- NIS2 Directive (EU 2022/2555) alignment for hospital deployments
- Notified-body change-evaluation memos for security updates
EU case context (anonymised)
Recent EU engagements include a German Class IIb monitoring device cleared with TÜV SÜD review feedback in two cycles, an Irish Class IIa SaMD that satisfied an MDCG 2019-16 gap report from BSI in a single resubmission, and a Swiss Class III implant programme aligned to IEC 81001-5-1 from architecture forward. Project names withheld under client NDA.
Blue Goat Cyber serves EU MedTech remotely from our US HQ. EU clients work with the same senior engineers that have shipped 250+ MedTech cybersecurity packages. EU enquiries: [email protected].
EU MedTech cybersecurity
Talk to a senior EU MDR cybersecurity engineer.
30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ submissions.