🇪🇺 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 medical device cybersecurity
What we deliver
- EU MDR Annex II/III technical documentation cybersecurity sections
- MDCG 2019-16-aligned cybersecurity risk management file
- IEC 81001-5-1 secure-software-lifecycle conformance evidence
- SBOMs (SPDX or CycloneDX) with VEX statements
- Penetration testing aligned to ENISA threat-landscape inputs
- Postmarket cybersecurity surveillance procedures and PSUR inputs
- NIS2 Directive readiness for hospital-deployed devices
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].
Fixed-fee, retest-included engagements
EU pricing in EUR; quotes typically range €18,000–€95,000 for a complete Class IIa/IIb cybersecurity package depending on architecture complexity. 24-hour proposal turnaround.
Pricing indicative; final quote depends on scope. VAT excluded.
EU MedTech cybersecurity
Get your EU MDR cybersecurity package notified-body-ready.
30-minute discovery call. Fixed-fee proposal in EUR within 24-hours. No commitment.