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.
General
How do you handle confidentiality and sensitive technical information?
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.
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.
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.
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.
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.
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.
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.
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’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.
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 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.