🇪🇺 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 Premarket Cybersecurity
What's included
- MDCG 2019-16 Rev.1 cybersecurity risk-management file
- IEC 81001-5-1 secure-development-lifecycle activity records
- Threat model with notified-body-ready traceability
- SBOM in SPDX or CycloneDX with VEX statements
- Verification and penetration test report
- Annex I §23 labelling text covering minimum IT requirements
- Postmarket cybersecurity surveillance procedure
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.