PCCP Cybersecurity ServicesPre-Authorize Security Changes the FDA Will Accept.
A Predetermined Change Control Plan lets you make planned changes after clearance without a new submission. We write the cybersecurity content of your PCCP: the security side of each planned change, the testing that proves it, and the tie-in to your postmarket plan and SBOM.
The short answer
What does PCCP cybersecurity work involve?
A Predetermined Change Control Plan (PCCP) lets the FDA approve planned device changes up front. The cybersecurity work covers how each planned change affects the attack surface, which security tests run before release and what counts as a pass, how security risk is assessed in the Impact Assessment, and how the plan fits with the postmarket cybersecurity plan and SBOM updates.
275+ FDA submissions supported, zero cybersecurity rejections. Built against the FDA's December 2024 PCCP guidance and February 2026 premarket guidance.
- AI/ML and non-AI devices
- Modification Protocol security
- Impact Assessment review
- SBOM and patch cadence
- Fixed fee
- Free 30-min call
- No obligation
- Senior expert, not a sales rep
- Fixed-fee quote in 24 hours
- NDA available on request
Why PCCPs draw cybersecurity questions
Most PCCPs are written by regulatory and engineering teams. The security content is often an afterthought, and reviewers notice.
Changes with no security analysis
Every planned change can alter the attack surface. If the Impact Assessment never says how, the reviewer asks, and the plan may be narrowed or rejected.
Vague testing methods
A Modification Protocol that says changes will be "security tested" gives the reviewer nothing to check. The plan needs named tests, pass criteria and when each test runs.
See an example PCCPNo link to postmarket work
A PCCP has to fit with your postmarket cybersecurity plan and SBOM updates. When the two documents disagree about how a fix ships, the gap shows up in review.
Postmarket monitoring guideWhat we deliver
We own the security content. Your regulatory team keeps ownership of the plan as a whole.
Description of Modifications
- Security review of each planned change
- Which changes touch the attack surface
- Boundaries that keep changes inside the plan
Modification Protocol
- Threat model update triggers
- SBOM refresh and vulnerability checks per change
- Security regression tests and pass criteria
- When a pen test is required, and its scope
Impact Assessment
- PCCP cybersecurity appendix tying each change to the threat model and risk assessment
- Security risk for each change, tied to your ISO 14971 file
- Exploitability and patient-harm review
- Residual risk and how it is accepted
Postmarket tie-in
- Which fixes go through the PCCP and which through your postmarket plan
- Update and patch cadence language
- Labeling and customer notice updates
How a PCCP engagement runs
- 01
Scoping call
We review your device, the changes you plan to make and your current threat model and hazard analysis, then send a fixed-fee quote.
- 02
Kickoff and intake
A project manager runs the engagement over Slack and secure file sharing. You share the draft PCCP, architecture, SBOM and risk file.
- 03
Drafting
We write the security sections of the plan and review the whole draft for security gaps, working alongside your regulatory team.
- 04
Review support
If the FDA asks questions about the security content, we help you answer them.
Reviewer-ready deliverables in one engagement
Every pccp cybersecurity services engagement ships with the artifacts FDA reviewers expect to see, traceable, complete, and aligned with current guidance.
- Security review of each planned change
- Modification Protocol test methods and pass criteria
- Impact Assessment tied to your ISO 14971 file
- Postmarket plan and SBOM tie-in
Pricing
Every engagement is a fixed fee, quoted after a free scoping call. No hourly billing.
PCCP Security Review
Fixed fee after scoping
You have a draft PCCP and want the security content checked before submission.
- Review of the Description of Modifications, Protocol and Impact Assessment
- Written list of gaps, ranked by priority
- Suggested wording for each gap
PCCP Security Authoring
Fixed fee after scoping
You need the security sections written, alongside your regulatory team.
- Security content for all three parts of the plan
- Threat model and SBOM update rules
- Security test methods and pass criteria
- Postmarket plan tie-in
Full Submission + PCCP
Fixed fee after scoping
You need the whole premarket cybersecurity package with a PCCP included.
- Everything in PCCP Security Authoring
- Threat model, SBOM, architecture views and labeling
- Penetration testing with retests until uncontrolled risks are closed
What drives the price
- Number and type of planned changes
- AI/ML model updates vs firmware, hardware or software changes
- Whether a current threat model and hazard analysis exist
- Whether the PCCP is part of a new submission or a later one
The FDA decides whether to authorize a PCCP. We make sure the security content is complete and clearly written.
PCCP Cybersecurity FAQs
PCCP Cybersecurity Services - scoped, fixed-fee, built for FDA premarket submissions.
A Predetermined Change Control Plan lets you make planned changes after clearance without a new submission. We write the cybersecurity content of your PCCP: the security side of each planned change, the testing that proves it, and the tie-in to your postmarket plan and SBOM.