Services
Advisor-Reviewed Services for Every Stage of Audit Readiness
Every engagement runs the same way: an AI-assisted first pass over the documents you already have, findings reviewed and approved by a qualified QMS advisor, and an action plan your team works through until the evidence is accepted.
01 / 05
Assessments
Start here. Find out where your quality system stands against QMSR, ISO 13485 and the audit ahead.
02 / 05
FDA Inspections and Enforcement
Prepare for an FDA inspection, rehearse it, and respond well if it ends with a Form 483 or a warning letter.
FDA Inspection Readiness (CP 7382.850)
FDA device inspection preparation built around Compliance Program 7382.850 and its risk-based approach.
Mock FDA Inspection
A practice FDA inspection in our Inspection Simulator, with an advisor playing the investigator.
PMA Pre-Approval Inspection Preparation
Getting Class III manufacturers ready for the facility inspection that accompanies PMA review.
BIMO (Clinical) Inspection Readiness
Readiness for FDA bioresearch monitoring inspections of device clinical studies: sponsors, CROs and sites.
Form 483 Response and Remediation
A structured, evidence-backed response to each Form 483 observation, and the remediation behind it.
Warning Letter Response and Remediation
A thorough, systemic response to an FDA warning letter, and the remediation and updates that follow it.
03 / 05
Quality System Remediation
Fix the parts of the quality system that audits most often find wanting, and keep them fixed.
CAPA System Remediation
Fixing a CAPA system auditors keep citing: the procedure, the records, root cause, effectiveness and backlog.
QMSR Transition
Bringing a QSR-era or ISO 13485 quality system in line with FDA's QMSR, which is now in effect.
Internal Audit Program
A risk-based internal audit program, run by your team or our advisors, with reports written for FDA to read.
Supplier Audits and Supplier Controls
Risk-based supplier selection, quality agreements, monitoring and supplier audits that hold up under QMSR.
Software Validation and Device Software (CSV, IEC 62304)
Validate software used in production and the QMS, and build device software on an IEC 62304 lifecycle.
04 / 05
Certification and Market Access
Certification audits, single-audit programs, EU market access and the quality evidence behind a submission.
ISO 13485 Certification Readiness
Prepare your QMS, records and people for a certification body's Stage 1 and Stage 2 audits.
MDSAP Readiness
Prepare for one audit covering ISO 13485 and the country-specific requirements of participating regulators.
EU MDR and IVDR Readiness
Prepare your QMS and technical documentation for notified body audits under the EU MDR or IVDR.
Submission Readiness (510(k), De Novo, PMA, Pre-Sub, 513(g))
The design, risk and V&V evidence behind a 510(k), De Novo or PMA, organized and gap-checked.
05 / 05
Build and Ongoing Support
A phased build for companies starting out, and continuous readiness for companies that want to stay ready.
Next Step
Not Sure Which Service You Need?
We usually recommend starting with a gap assessment. Tell us what's ahead and an advisor will recommend where to begin. Please don't send confidential documents yet: secure upload is set up after onboarding.
