Inspection-Ready Risk Management & Quality Systems | ISO 14971, ISO 13485 & 21 CFR 820
Risk management and quality systems aren't paperwork exercises—they're operational frameworks that determine whether your device gets approved, stays on the market, and survives inspections. We build ISO 14971 risk files, ISO 13485 QMS foundations, design controls, process validation, and supplier management programs that hold up under regulatory scrutiny.
Why Risk Management & Quality Systems Break
Most quality system failures aren't "bad manufacturing"—they're disconnected documentation: risk files that don't link to design verification, design controls with no traceability to requirements, process validations that miss critical parameters, and supplier controls that exist on paper only. We help you build integrated systems where risk management drives design, design drives manufacturing, and all of it connects to your regulatory submissions.
- ISO 14971 integration: risk management files that connect to design inputs, verification, labeling, and post-market surveillance.
- Design controls: requirements traceability, design reviews, verification/validation protocols, and design transfer packages.
- Process validation: installation/operational/performance qualification for critical manufacturing processes and sterilization.
- Supplier quality: approved supplier programs, incoming inspection, and change control that prevent supply chain failures.
Risk Management & QMS Programs
Structured programs you can implement fast—then defend under inspection.
ISO 14971 Risk Management File Build
Typical range: $8,000–$30,000
For devices needing complete risk management documentation from hazard identification through residual risk evaluation.
- Hazard identification workshops, risk estimation (probability/severity), and risk evaluation criteria
- Risk control measures linked to design features, manufacturing controls, and labeling
- Risk-benefit analysis, residual risk evaluation, and post-market risk review framework
Design Controls & DHF Build
Typical range: $12,000–$50,000+
For teams needing compliant design history files with complete traceability from user needs through design transfer.
- Design planning, user needs analysis, and design input specifications
- Design verification and validation protocols, traceability matrices, and design review records
- Design transfer packages, design change control, and DHF organization for submissions
ISO 13485 QMS Implementation
Typical range: $20,000–$80,000+
For companies building foundational quality systems or preparing for ISO 13485 certification and regulatory inspections.
- Quality manual, management review framework, and document/record control procedures
- Internal audit program, nonconformance management, and preventive action processes
- Training records, competency assessment, and continuous improvement cycles
Process Validation & Manufacturing Controls
Typical range: $15,000–$70,000+
For critical manufacturing processes requiring IQ/OQ/PQ protocols, statistical process control, and continued process verification.
- Process characterization, critical parameter identification, and acceptance criteria definition
- Installation/operational/performance qualification protocols and execution support
- Continued process verification plans, statistical methods, and revalidation triggers
Who We Help
Startups Building First QMS
Early-stage companies needing foundational quality systems that scale from prototype through commercial production.
Pre-Submission Risk Files
Teams preparing 510(k) or PMA submissions needing complete ISO 14971 documentation and design control records.
Design Transfer Challenges
Companies struggling to move from development to manufacturing with complete traceability and process controls.
ISO 13485 Certification
Organizations pursuing ISO 13485 certification for EU MDR compliance or as commercial requirement from partners.
Inspection Remediation
Teams recovering from FDA 483 observations or warning letters needing rapid CAPA and system improvements.
Manufacturing Scale-Up
Companies moving from low-volume to commercial production needing validated processes and supplier controls.
How We Run Risk & QMS Engagements
We build systems that connect risk management, design controls, and manufacturing—so your records tell a coherent story.
Current State & Gaps
We assess existing risk files, design records, and quality procedures to identify gaps that will fail in submissions or inspections.
Risk & Design Controls
We develop ISO 14971 risk files, design control procedures, and traceability matrices that connect requirements through validation.
Process & Supplier Controls
We establish process validation protocols, supplier qualification programs, and manufacturing controls that ensure consistency.
Inspections & Audits
We organize documentation, train teams on inspection response, and prepare audit-ready evidence packages.
Risk Management & QMS FAQs
Do we need ISO 14971 for a 510(k) submission?
Yes, in practice. While FDA doesn't explicitly require ISO 14971 compliance, the standard provides the framework FDA expects for hazard identification, risk controls, and risk-benefit analysis. Most successful submissions include ISO 14971-aligned risk management documentation.
What's the difference between design verification and validation?
Verification confirms you built the device right (meets design specifications). Validation confirms you built the right device (meets user needs and intended use). Both require documented protocols, acceptance criteria, and traceability to design inputs.
When do we need process validation?
For any manufacturing process where you can't fully verify the output through inspection or testing—like sterilization, welding, molding, or aseptic processing. Also required when process parameters significantly affect device performance or safety.
Are these pricing ranges fixed?
No—these are typical working bands. After a triage call we provide a fixed or milestone quote based on device complexity, system maturity, team size, and whether you need document creation, gap remediation, or full system implementation.