Fractional Product Security Leadership
A virtual (fractional) product security office gives a small medical device manufacturer access to senior medical device cybersecurity leadership and a working security program — without the cost of a full-time in-house team.
When fractional leadership makes sense
Startups pre-Series B
You need credible product security leadership for diligence and regulatory conversations, before the budget for a full-time executive hire makes sense.
Companies responding to FDA findings or Warning Letters
You need experienced leadership to direct the response, engage with the agency, and rebuild a defensible program quickly.
Teams scaling AI-enabled products rapidly
Your product security needs are outpacing your current organizational structure as AI-enabled features ship faster than your team can evaluate the risk.
What this covers
Strategic leadership, on a fractional basis
An experienced product security officer or virtual CISO sets direction, owns the security program, and represents your company to regulators, auditors, and customers — reporting directly to executive leadership or the board, without the cost of a full-time executive salary.
Regulatory and standards alignment
Guidance on meeting FDA premarket and postmarket cybersecurity expectations (including the FDA's 2023 guidance and related eSTAR requirements), EU MDR Annex I cybersecurity essential requirements, IEC 62443, IEC 81001-5-1, and AAMI/UL frameworks — translated into practical requirements your engineering team can actually implement.
Secure product development lifecycle support
Building or maturing a secure development lifecycle: threat modeling, risk management integrated with ISO 14971, architecture review, and secure coding practices embedded into your existing product development rather than bolted on afterward.
Premarket submission support
Preparing cybersecurity documentation for FDA submissions — SBOM, threat models, security risk assessments, cybersecurity testing evidence, labeling — and MDR technical documentation, reducing the risk of review cycles or deficiency letters.
Postmarket vulnerability management
Establishing coordinated vulnerability disclosure processes, SBOM management, patch and update strategy, incident response planning, and monitoring for compliance with postmarket surveillance obligations.
Team enablement and process building
Training your internal engineering and quality teams, writing policies and procedures, and establishing repeatable processes so your company gradually builds internal capability rather than remaining dependent indefinitely.
Scaled to actual need, not a fixed package
A few days a month, project-based, or an ongoing retainer — engagement scales up or down as your company grows or as submission deadlines approach, so you get senior-level expertise at a cost a full-time hire wouldn't allow.
Project Advisory
For a specific, time-boxed need
Scoped engagements for a defined situation — a Warning Letter response, board prep ahead of a raise, or an inspection-readiness sprint. No recurring commitment.
Ask about this optionvPSO — Virtual Product Security Officer
For ongoing fractional leadership
A named Aktriva executive serves as your fractional Product Security Officer on an ongoing monthly retainer — recurring board reporting, standing availability for risk decisions, and continuity across quarters rather than a one-off engagement.
Ask about this optionWhat a vPSO does
- Recurring board and leadership reporting on product security posture
- Standing availability for risk acceptance and benefit-risk decisions as they come up, not just on a schedule
- Direct engagement with FDA and Notified Bodies when an inspection or response is underway
- One named executive point of contact, providing continuity across quarters — not a rotating advisory pool
Need senior security leadership on your team?
Tell us about your organization's stage and what's prompting the need — we'll figure out the right scope together.