Regulatory Compliance

Regulatory Compliance Support for Health-Tech Organizations

Quality Commercial Consultants (QCC) provides quality and regulatory compliance consulting for medical device and health-tech organizations that need audit-ready documentation and predictable compliance outcomes. We help you interpret applicable requirements, identify gaps, and build evidence that stands up to regulatory review and audits.

What We Deliver

Depending on your goals and current state, deliverables may include:

QMS compliance planning aligned to FDA expectations and ISO 13485 principles.
Gap analysis against applicable regulations and relevant consensus standards.
Documentation planning to improve traceability and audit readiness.
Compliance risk identification and support preparing for audits and regulatory interactions.
Integration of compliance evidence into submission documentation where needed.

Why It Matters

A compliance-oriented approach reduces surprises during inspections and audits and helps prevent avoidable delays during submissions. Clear documentation and traceability make it easier to demonstrate that your system supports safe, effective device development and lifecycle management.

FAQs

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.