ISO 13485:2016 Medical Device QMS
From design controls to post-market surveillance — regulatory-ready quality management.
Where Companies Struggle
ISO 13485 certification demands more than a quality manual. These are the real obstacles I help you overcome.
Regulatory Complexity
MDR alignment, notified body expectations, and evolving standards require deep expertise.
Design Control Integration
Embedding design and development controls into your existing workflows without disruption.
Post-Market Obligations
Vigilance reporting, PMCF studies, and periodic safety updates — structured and sustainable.
A Proven Path to Certification
Four structured phases that take you from wherever you are today to a successful notified body audit.
Gap Analysis & Regulatory Mapping
Assessment against ISO 13485 and MDR/IVDR requirements. Risk-based prioritization.
QMS Design & Documentation
Build a medical device QMS that satisfies notified bodies — practical, not bureaucratic.
Evidence Collection & Validation
Structured evidence for every clause. Traceability from requirement to proof.
Audit Preparation & Notified Body
Mock audits, team preparation, corrective actions — ready for Stage 1 and Stage 2.
Every Aspect of Your Medical Device QMS
Comprehensive coverage across all critical ISO 13485 domains.
Clause Mapping
Every ISO 13485 requirement linked to procedures, records, and evidence.
Design History File
Structured DHF management with design input/output traceability.
Risk Management
ISO 14971 integration — hazard analysis, risk controls, residual risk.
CAPA System
Corrective and preventive action tracking with effectiveness verification.
Supplier Quality
Supplier evaluation, approved supplier list, incoming inspection management.
Post-Market Surveillance
Complaint handling, vigilance reporting, trend analysis.
From Kickoff to Certification
A realistic, structured schedule that accounts for your device classification and existing QMS maturity.
Gap Analysis & Planning
Assessment against ISO 13485 and MDR requirements .
QMS Implementation
Build documentation, design controls, CAPA system .
Pre-Audit & Optimization
Internal audit, close gaps, team preparation .
Certification Audit
Successful ISO 13485 certification.
Start Your ISO 13485 Certification
Free initial consultation: I'll assess your starting position and create a roadmap.
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Let's talk. Concrete, no-obligation, tailored to your situation. I'll give you an honest assessment and a clear path forward.