Services / MD QMS Apex
MD QMS Apex · Security engineering
MedTech security leadership
Security does not stop at clearance. We provide ongoing security leadership for device and health-software companies: vulnerability management, SBOM monitoring, ISO 27001 and board reporting.
Why it matters
Post-market cybersecurity commitments made in a submission have to be kept: monitoring components, triaging vulnerabilities and communicating with users.
Health-software companies selling to hospitals, insurers and the NHS are increasingly asked for ISO 27001 or equivalent evidence before contracts are signed.
Who it’s for
- Device companies with post-market cybersecurity commitments
- Digital-health and HealthTech companies needing ISO 27001
What’s included
- Virtual CISO: security strategy, policy and risk ownership
- Post-market vulnerability management and SBOM monitoring
- ISO/IEC 27001 implementation and audit preparation, led by an ISO/IEC 27001:2022 Lead Auditor
- Security questionnaire and customer due-diligence support
- Board-level security reporting
Deliverable
Ongoing security leadership.
Everything we write is yours to own and maintain. We stay available for auditor or reviewer questions on anything we produced.
How it works
Discover
A free 30-minute call to understand your product, markets and deadline.
Define scope
A fixed-fee proposal within two working days: deliverables, exclusions, timeline and price.
Build evidence
We do the work with your team, not around it. Everything is written for you to own.
Support delivery
We stay with you through audits, submissions and reviewer questions on anything we wrote.
Questions we’re often asked
Do you also support Azure environments?
Yes. For existing clients we review Azure security and governance for regulated workloads as part of the retainer or as a separate piece of work.
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Talk to us about Security leadership
Book a free 30-minute discovery call. We’ll understand your product and deadline, and tell you exactly what an engagement would involve and cost. No obligation.