Service
Quality systems
Documentation, gap assessment, and audit readiness against ISO 13485 and FDA's QMSR.
What this covers
FDA's Quality Management System Regulation took effect on February 2, 2026. It amends 21 CFR Part 820 to incorporate ISO 13485:2016 by reference, so a startup now builds one system for both the registrar and the agency. We help you build it at the size you are, not the size a template assumes.
Design controls first
An investigational device is exempt from most of the quality system regulation, but not from design controls. That is the part you must have in place before the IDE: design inputs and outputs, reviews, verification and validation with traceability, and a design history file a reviewer can follow.
Gap assessment and documentation
We assess what you have against ISO 13485 and the QMSR, write the gap report with priorities, and draft the procedures you are missing: document and record control, risk management under ISO 14971, supplier controls, CAPA, complaint handling, and the rest as your stage requires.
Audit readiness
Before a registrar audit or an FDA inspection, we run the audit ourselves and give you the findings first. We do not certify. Certification is the registrar's decision and inspection is FDA's. Our job is to make sure neither one finds anything you did not already know.
When you need it
Before the IDE, for design controls: FDA can ask for the design history file at any point in the review. Before a registrar audit or a first FDA inspection, for the rest of the system. A procedure written while the team is small costs less than one retrofitted around its habits.
What you receive
- Gap reportEvery clause, your status against it, and the order to close the gaps in.
- Procedure setDrafted to your organization and your device, reviewed with the people who will follow them.
- Design history file structureThe index and templates a reviewer expects to find.
- Mock audit reportFindings graded as an auditor would grade them, with corrective actions.
What we need from you
- Current procedures and recordsWhatever exists, in whatever state.
- Design history to dateDrawings, test reports, and the decisions behind them.
- Supplier listContract manufacturers, critical component suppliers, and test labs.
- An owner for qualityOne person in your company who holds the system after we leave.
Tell us where your program is.
We reply within 12 hours. You get a written scope and estimate before any work starts.