ISO 13485 Compliance. Right-Sized for Your Stage.

Build quality into the foundation — not into the final inspection. We build right-sized QMS frameworks that satisfy regulators today and scale with your operations tomorrow.

The Problem We Solve

FDA registration, CE marking, and most distribution and hospital partnerships require an active, audited QMS. Most early-stage device companies either over-engineer their QMS — wasting resources — or under-document it — failing audits. We build right-sized QMS frameworks that satisfy regulators today and scale with your operations tomorrow.

What We Do

Four QMS disciplines — built for real operations, not just audit appearances.

📋 ISO 13485:2016 Implementation

Gap assessment against current ISO 13485 requirements
QMS framework design and document architecture
Standard Operating Procedures (SOPs) authoring
Work instructions and controlled forms development
Internal audit program design and execution
Certification audit preparation and support

📁 Design Controls & DHF / DMR / DHR

Design History File (DHF) structure and document control setup
Device Master Record (DMR) template and population
Device History Record (DHR) process design
Design control procedure aligned to 21 CFR Part 820 and ISO 13485
Traceability matrix from user needs to verification evidence

⚠️ Risk Management — ISO 14971

Risk management plan development
Hazard identification and risk analysis workshops
Risk evaluation and control measure definition
Residual risk acceptability review and sign-off
Post-production risk monitoring and update triggers

🔄 CAPA & Complaint Handling

Corrective and Preventive Action (CAPA) process design
Root cause analysis methodology: 5-Why, Fishbone, FTA
Complaint intake, investigation, and closure workflows
Regulatory reportability determination process
Trend analysis, KPI dashboards, and management review inputs

Who This Is For

We work with device companies at every QMS maturity level — from first setup to audit remediation.

Pre-commercial device companies preparing for their first regulatory submission

Companies that have failed or are at risk of failing an upcoming quality audit

Startups needing ISO 13485 certification to access distribution partners or hospital tenders

Device makers whose QMS documentation is not aligned to current standards

Manufacturing partners required to hold a compliant QMS as a condition of working with a global OEM

Why 369 Innovations

We build QMS frameworks that work in practice — not documents produced to satisfy an auditor that no one follows. Every procedure we write is tested against your actual operations, and we train your team to own it — not depend on external consultants to maintain it.

Key Differentiator: A functional, audit-ready QMS your team actually operates — not a binder on a shelf.