Deep dives on FDA expectations, threat modeling, penetration testing, SDLC, and the standards your team is being asked to meet.
Showing 12 of 292 articles · Page 11 of 25
Cybersecurity for Faster FDA Approval: a practical 2026 playbook for MedTech leaders, what to prioritize, how the FDA expects it framed, and where teams stumble.
Read article
MedTech Cybersecurity Leadership: a practical 2026 playbook for MedTech leaders, what to prioritize, how the FDA expects it framed, and where teams stumble.
Read article
Discover the top 10 medical device cybersecurity vulnerabilities from real-world penetration testing & learn how to protect patients and meet FDA.
Read article
FDA Cybersecurity Rules (Beyond Red Tape) for medical device manufacturers: what the FDA expects in 2026, gaps that trigger deficiencies, and evidence to prepare.
Read article
The PATCH Act only applies to new medical devices. Legacy medical devices pose significant cybersecurity risks because they lack modern protections.
Read article
Ventilator Cybersecurity Recall Lessons: a practical 2026 playbook for MedTech leaders, what to prioritize, how the FDA expects it framed, and where teams stumble.
Read article
Medical device cybersecurity traceability links risks, controls, and verifications throughout a device's lifecycle. Aligned with the FDA's Feb 3, 2026.
Read article
Top Medical Device Cyber Threats in medical devices: attack scenarios, patient-safety impact, and mitigations FDA reviewers expect in 2026 submissions.
Read article
The 14 medical device cybersecurity standards FDA reviewers expect - ISO 14971, IEC 62304/81001-5-1, AAMI TIR57/TIR97, UL 2900 - mapped to SPDF artifacts.
Read article
Navigating the FDA clearance process for medical devices involves more than technical documentation and testing - it involves significant regulatory.
Read article
Search the FDA 510(k), De Novo, and PMA databases for cybersecurity precedent, product codes, and predicate devices before a Section 524B premarket filing.
Read article
Cybersecurity in MedTech Go-to-Market: a practical 2026 playbook for MedTech leaders, what to prioritize, how the FDA expects it framed, and where teams stumble.
Read article30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ FDA submissions.
