Put threat modeling, SBOM maintenance, security testing, and vulnerability handling into the quality procedures your team already runs. Fixed fee after scoping. Your quality team approves and owns the QMS.
Device cybersecurity evidence needs owners, controlled versions, and review triggers. Blue Goat drafts the agreed SOPs, forms, and evidence map. Your team reviews, approves, and implements them. This is product cybersecurity work. It is not full QMS implementation, ISO 13485 certification, or verification and validation.
QMS integration means building your cybersecurity documents into your quality management system. Your threat model, SBOM, security risk assessment, test reports, and vulnerability records become controlled quality records. Each one gets an owner, a version history, and defined triggers for review. Design control, change control, supplier control, CAPA, and complaint handling then account for cybersecurity.
Procedure list · templates · evidence
Agreed scope and fixed-fee quote
SOPs · forms · evidence map
Drafts in your document format
Engineering · security · quality
Revised agreed documents
Document control · training · records
Manufacturer-approved procedures
These are common starting points. They describe typical situations, not specific client results.
The threat model and SBOM were written for a submission and sit in a shared folder. No procedure says who updates them or when.
Software, component, and supplier changes go through change control, but nothing asks whether they affect cybersecurity.
A new vulnerability arrives. It is unclear whether it goes to complaints, CAPA, or engineering, and who decides.
Standalone service
QMS integration is its own service. You do not need a premarket submission or a consulting retainer to buy it. Every engagement is a fixed fee, agreed in writing after a scoping call and a review of your procedure list.
Fixed fee per agreed procedure
Fixed fee after scoping
Not included: full QMS implementation, ISO 13485 certification, verification and validation, and approval of procedures. Your quality team owns and approves the QMS.
Already working with us? QMS integration can also be added to the FDA Premarket Cybersecurity Package or a consulting engagement.
Security requirements, design reviews, testing, and change decisions in the procedures you already run.
Owner, controlled version, and review triggers for the threat model.
How your team creates, reviews, approves, and updates the SBOM for each release.
Review, drafting, process-owner review, manufacturer approval, and rollout.
Tell us which procedures you need.
Starter SOPs, record templates, and what the fixed fee covers.
QMS integration covers your cybersecurity documents. We also help medtech innovators build the full product cybersecurity program, including a secure software development lifecycle (SSDLC), threat modeling, SBOM management, security testing, and vulnerability handling.
Explore cybersecurity program consultingThe FDA's premarket cybersecurity guidance addresses quality management system considerations, and the QMSR incorporates ISO 13485 by reference. Cybersecurity evidence should be maintained through your quality processes, not as one-time submission documents.
No. Blue Goat operates an ISO 13485-aligned QMS and is not ISO 13485 certified. We do not implement or certify your QMS. Your quality team owns and approves every procedure.
Yes. Buy it standalone, or add it to a premarket submission or consulting engagement. You receive a fixed-fee quote after scoping.
Agreed SOP drafts or revisions, record templates, an evidence map, and rollout support as scoped. Your team reviews, approves, and implements them.
Tell us which procedures you need, your device context, and your current QMS gaps. You receive a written fixed-fee quote. Agree confidential handling before sharing controlled documents.
