Protect PHI/PII, clinical data, and device ecosystems with a certified-ready ISMS. We implement and audit ISO/IEC 27001:2022, integrate IEC 81001-5-1 cybersecurity for health software, and align with ISO 13485, ISO 14971, and IEC 62304—for SaMD and traditional (connected) medical devices.
EU & US coverage • MedTech-first approach • Calm, predictable audits
Right-size your ISMS to your device portfolio and cloud footprint.
Pragmatic policies and controls that your team can actually run.
Embed security into your SDLC for SaMD and connected devices.
Control third-party and cloud risk across your stack.
Prepare for ISO/IEC 27001 certification with confidence.
Independent validation of products and infrastructure under our oversight.
We ensure information security evidence supports device safety, performance, and labeling claims.
Optional extensions to privacy frameworks can be coordinated on request.
| Deliverable | Purpose | Typical outputs |
|---|---|---|
| ISMS scope & context | Define what’s in scope and why | Scope statement, stakeholder needs, interfaces |
| Risk assessment & treatment | Identify and treat information risks | Method, risk register, treatment plan |
| Statement of Applicability (SoA) | Document Annex A control decisions | Control selection, justification, implementation status |
| Policy & control set | Operate the ISMS day-to-day | Access, change, vendor, incident, backup/DR, logs |
| Product security pack | Secure SDLC for SaMD/devices | Threat model, SBOM, vuln handling, release & maintenance |
| Training & awareness | Build secure habits | Training matrix, content, attendance & effectiveness |
| Metrics & management review | Drive continual improvement | KPIs/KRIs, audit results, CAPA, decisions & actions |
Penetration testing and eQMS/ISMS tooling can be added via partners under our direction.
Objective audits to ISO/IEC 27001:2022 with actionable findings.
Guide you through Stage 1 & Stage 2 with calm confidence.
Yes. We secure products and platforms across device, app, and cloud—tying controls to safety, performance, and labeling.
Absolutely. We align ISMS processes with design control, risk, CAPA, supplier management, and PMS to avoid duplicate work.
Yes, via vetted partners under our oversight. Results feed directly into risk treatment and vulnerability handling.
After discovery, we provide a dated plan with owners and deliverables. Timing depends on scope, resources, and existing maturity.
Yes. We treat shared information as confidential and can use your NDA or ours.
Book an ISMS consultation. We’ll outline scope, controls, and a practical plan to reach ISO/IEC 27001:2022 readiness—optimized for Medical Devices and SaMD.