Connect device cybersecurity evidence to the way your team already works: procedures, records, owners, and change triggers inside your existing QMS.
Scoped within FDA premarket cybersecurity services or MedTech Security Advisory.
Compare your existing procedures for design control, risk management, supplier control, change control, CAPA, complaints, and postmarket surveillance against the cybersecurity work your devices need.
Draft revisions for threat modeling, security requirements, security testing, SBOM maintenance, vulnerability handling, and coordinated disclosure. Your quality team reviews and approves them.
Connect threats, security requirements, risks, controls, and test evidence to the records you already keep, with named owners and approval steps.
Define which software, component, supplier, and threat changes trigger a cybersecurity review, and what suppliers must give you, such as SBOMs and vulnerability notices.
Route vulnerability intake, triage, and incident response into the teams and records responsible, including links to complaints and CAPA.
Walk the teams through the revised procedures and a worked example, with record templates and a prioritized implementation plan.
A fictional manufacturer, simplified to show how one procedure change closes a gap.
A fictional Class II infusion pump maker has a premarket package: threat model, SBOM, pen test report, and security risk assessment. Its QMS has no procedure saying who updates them or when.
A supplier releases a new Wi-Fi module firmware. Engineering ships it. Nobody checks whether the SBOM, threat model, or risk assessment changed, because change control only asks about safety and performance.
The change control form gains a cybersecurity impact question. A yes answer opens a cybersecurity change assessment owned by product security and approved by quality.
The assessment updates the SBOM entry, checks the new firmware against known vulnerabilities, revisits threats on the Wi-Fi interface, and records whether retesting is needed.
The supplier agreement now requires an SBOM and vulnerability notification for each firmware release.
The next firmware change produces a traceable record: change request, impact assessment, updated SBOM, threat review, test decision, and quality approval. The manufacturer made every decision.
Deliverables are agreed after review: a gap assessment, procedure revisions, record templates, an evidence map, and a prioritized implementation plan. We do not publish fixed prices because the work depends on what your quality system already has.
Tell us about your device, your quality system, and what needs connecting. We reply within one business day to schedule a short review.
