Guidance IEC 62304 ISO 14971 ISO 27001 UL 2900 AAMI TIR57/TIR97 NIST Cybersecurity Framework NIST SP 800-53 HIPAA...
(e.g., AAMI) as appropriate. Required Qualifications Bachelor’s degree in Microbiology, Chemical Engineering...
– Microbiological Methods ISO 11138 Series – Biological Indicators ISO 10993 Series – Biological Evaluation AAMI TIR52 Professional...
notification (e.g.: FDA cybersecurity guidelines, 95/46/ED, HIPAA, GDPR, ISO 13485, ISO 14971. AAMI TIR 57;21CFR820, SB1386...
, and testable Derive cybersecurity requirements from FDA guidance and consensus standards (IEC 62443, IEC 81001-5-1, AAMI SW96... with system-level threat modeling methodologies (e.g., STRIDE, PASTA, or TARA as defined in IEC 81001-5-1 / AAMI SW96) Working...
regulatory security submissions, ensuring compliance with FDA Cybersecurity Guidance (2025), EU MDR, NIST 800-53, IMDRF, and AAMI...
Cybersecurity Guidance (2025), EU MDR, NIST 800-53, IMDRF, and AAMI TIR57. Knowledge of real-time operating systems hardening...
into the SDLC and QMS in alignment with FDA cybersecurity guidance and AAMI TIR57. Guides software development teams in the... knowledge of FDA premarket and postmarket cybersecurity guidance and applicable standards (e.g., AAMI TIR57). Demonstrated...
knowledge of FDA Quality System requirements, ISO 13485, quality risk management, and applicable USP, AAMI, ASTM, or ISO...
human factors and usability (FDA guidance, AAMI HE 75, ISO 62366, IEC 60601-1-6, ISO 11607-1). Experience ensuring...