Frequently Asked Questions (FAQ)

General FAQs

What kinds of companies do you work with?
QCC supports software-enabled medical device and SaMD sponsors, as well as HealthTech vendors and suppliers who need quality, regulatory, and cybersecurity compliance documentation that stands up to review.
When should we engage QCC?
Engage QCC when you have a submission date, an FDA Additional Information (AI) deadline, an upcoming audit, a client diligence request, or when your documentation is fragmented, and you need a clear plan to get to “submission-ready.”
What’s the first step to get started?
QCC will schedule a short consultation with you to understand your device/program scope, timeline, regulatory context, and what artifacts you already have. After that, QCC provides a scoped plan with deliverables and milestones.
What inputs do you typically need from our team?
Usually: intended use/claims, system architecture overview, risk documentation, test evidence (or plans), existing SOPs/QMS artifacts (if applicable), and any reviewer/auditor questions or diligence criteria you’ve received.
What deliverables do you produce?
Deliverables are documentation and evidence packages tailored to your context—submission-ready narratives, traceability artifacts, risk-to-test alignment, compliance evidence, and response packages for AI requests, audits, or diligence reviews.
Do you provide “templates” or a solution-in-a-box?
No. QCC meets you where you are, works within your existing tools and workflows, and produces documentation that reflects how your team actually operates. Templates may be used selectively, but only when they accelerate outcomes and fit your environment.
Will you require us to adopt new tools or platforms?
Not by default. QCC works with your current systems (eQMS, ticketing, document control, repositories). Additional tools are recommended only when there’s a clear, practical benefit.
How do you work with engineering teams without slowing them down?
QCC focuses on the minimum documentation needed to be clear and defensible, builds from existing technical artifacts, and creates reviewer-friendly structure and traceability without changing how engineering delivers work.
Can you help if we’re already in active FDA review?
Yes. QCC can triage gaps, organize responses, and produce targeted documentation to support AI requests or other review follow-ups—prioritizing what will reduce back-and-forth.
Do you provide ongoing support or only project-based work?
Both. QCC can support focused deliverables (e.g., a submission package) or provide long-term partnership support to evolve your QMS and compliance posture over time.
Do you work with international requirements (e.g., ISO 13485, MDSAP, EU MDR)?
Yes. QCC supports quality system alignment and audit readiness, including ISO 13485 and MDSAP contexts, and can help map documentation to multiple regulatory expectations when needed.
How do you handle confidentiality and sensitive technical information?
QCC operates under NDA and treats technical, regulatory, and security information as confidential. Access is kept minimal and scoped to what’s needed to deliver the work.

FDA 510(k) Cybersecurity Testing

Who does cybersecurity testing support apply to?

Cybersecurity testing support applies to:

  • Manufacturers of software-enabled or connected medical devices that include cybersecurity information as part of an FDA 510(k) submission.
  • Regulatory and quality teams that prepare and maintain submission-ready documentation.
  • Engineering and product teams that implement and verify cybersecurity risk control measures.
  • Organizations that seek to align internal cybersecurity testing activities with FDA premarket review expectations.
What inputs are typically required from a sponsor?

Sponsors typically provide inputs such as:

  • Device architecture descriptions and software design documentation.
  • Cybersecurity risk analyses, threat models, or security risk assessments.
  • Existing cybersecurity testing artifacts, including vulnerability assessments and penetration testing results, where available.
  • Intended regulatory pathway and submission format (e.g., eSTAR).
What cybersecurity testing deliverables support an FDA 510(k) submission?

Cybersecurity testing deliverables that support FDA premarket review include:

  • Cybersecurity test plans that define test objectives, scope, and risk-based rationale.
  • Summaries of vulnerability assessment and penetration testing results with traceability to identified risks and implemented risk control measures.
  • Documentation formatted for FDA review, including narrative descriptions, tables, and traceability matrices.
  • Support for integrating cybersecurity testing evidence into the overall FDA 510(k) submission structure.

FDA 510(k) Cybersecurity Docs

Who is FDA 510(k) cybersecurity documentation support for?
This service supports manufacturers of software-enabled or connected medical devices and SaMD preparing an FDA 510(k) submission where cybersecurity documentation is required or expected.
What inputs do you typically need from a sponsor?
Typical inputs include device architecture and software design documentation, third-party component inventories (for SBOM), cybersecurity risk analyses or threat models, existing cybersecurity testing artifacts (if available), and your intended submission format (e.g., eSTAR).
What deliverables do you provide?
Deliverables may include submission-ready cybersecurity narratives, SBOM documentation, risk/threat modeling summaries, lifecycle vulnerability management documentation, and traceability artifacts formatted for FDA review.
Does QCC perform cybersecurity testing?
QCC focuses on regulatory documentation and evidence packaging. We can help interpret and integrate testing results you already have (or plan), but we do not replace a sponsor’s testing execution responsibilities.

Federal Programs Cybersecurity Docs

Who is this service intended for?
This service supports organizations applying for, administering, or reporting on federally funded programs where cybersecurity planning and documentation are required as a condition of funding.
What inputs do you typically need?
Typical inputs include the NOFO or grant requirements, project scope and deliverables, any existing risk assessment or planning artifacts, and any required reporting templates or agency-specific expectations.
What deliverables do you provide?
Deliverables may include grant-aligned cybersecurity plans, risk assessment summaries, mitigation documentation suitable for submission, and support packaging artifacts for applications and post-award reporting.
What is (and is not) included?
Work is scoped to compliance documentation tied to federal funding requirements, not enterprise-wide cybersecurity program design or unrelated policy development.

FDA 510(k) AI/ML Docs

Who is FDA 510(k) AI/ML documentation support intended for?
This service supports sponsors developing AI/ML-enabled medical devices (including SaMD), preparing a 510(k) submission where AI/ML functionality is part of the intended use, performance claims, or risk profile.
What inputs do you typically need from a sponsor?
Typical inputs include model purpose and architecture descriptions, data documentation for training/validation, performance results, identified risks and controls, and any internal evaluation artifacts relevant to claims and limitations.
What deliverables do you provide?
Deliverables may include submission-ready AI/ML documentation packages, reviewer-focused narratives explaining data and performance, risk-based rationale for controls, and traceability matrices linking evidence to submission sections.
Does QCC build or optimize AI/ML models?
No. QCC focuses on regulatory documentation and evidence packaging for review; algorithm development and proprietary optimization remain with the sponsor.

510(k) Submission Support

Who is 510(k) submission support intended for?
This service supports medical device and SaMD sponsors preparing an FDA 510(k) submission and needing structured, submission-ready documentation aligned to current review practices.
What inputs do you typically need?
Typical inputs include device description and intended use, predicate/comparator information, performance evidence (bench/software/clinical as applicable), labeling, risk analyses, and any specialized documentation (e.g., cybersecurity, AI/ML).
What deliverables do you provide?
Deliverables may include an organized 510(k) submission package formatted for eSTAR, evidence mapping and traceability artifacts, quality checks for consistency, and support preparing for and responding to interactive review or AI requests.
What is not included?
This service does not replace execution of testing, device design work, or internal quality system implementation; it focuses on submission readiness and regulatory alignment.

Regulatory Compliance

Who is regulatory compliance consulting intended for?
This service supports medical device and health-tech organizations preparing for regulatory submissions or audits, and teams responsible for compliance readiness and quality system performance.
What inputs do you typically need?
Typical inputs include your quality system documentation (procedures/records), any available submission artifacts, internal audit reports (if available), and your regulatory jurisdictions and timelines.
What deliverables do you provide?
Deliverables may include compliance gap analysis reports, documentation templates or improvements, traceability artifacts linking requirements to practices, compliance risk identification/mitigation documentation, and support for audit and regulatory interactions.
What’s included in scope (and what isn’t)?
Work is scoped to regulatory-relevant compliance evidence and milestones, not broad operational transformation unrelated to submissions or audit outcomes.

HealthTech Regulatory Compliance

Who is HealthTech regulatory compliance support intended for?
This service supports HealthTech vendors and technology partners who need to meet regulated client quality system expectations (e.g., supplier audits, diligence, onboarding requirements) even when they are not regulated as device manufacturers.
What inputs do you typically need?
Typical inputs include client audit reports or questionnaires, existing process and quality documentation, any current compliance artifacts or controls, and context on the client standards or regulatory references being applied.
What deliverables do you provide?
Deliverables may include a gap analysis mapped to client criteria, audit-ready documentation/templates, traceability artifacts linking criteria to practices, supplier quality evidence packages, and response packages for client/audit inquiries.
What is not included?
This service focuses on client-driven compliance evidence; it does not provide internal process optimization unrelated to regulated client audit outcomes.

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