ISO 13485:2016 — QMS for Medical Devices
From risk analysis to Design History File — fully regulatory compliant. QMS for Medical Device Manufacturers.
Your Challenges
Regulatory Requirements
Correctly implementing Design Controls, Risk Management and Post-Market Surveillance
Design History File
Documenting the development process without gaps and ensuring full traceability
Notified Bodies
Preparing for Notified Body audits and demonstrating conformity
Our Approach
Regulatory Gap Analysis
Systematically assess ISO 13485 + MDR/IVDR requirements. Prioritisation by audit relevance.
QMS & Process Setup
Design & Development process, Supplier Management, Change Control — documented audit-ready.
Evidence Collection & DHF Management
Organise development evidence, test reports and risk files centrally and audit-ready.
Notified Body Audit Prep
Mock audit with regulatory expertise, address critical points, brief your team.
Software Support
DHF Management
Structured Design History Files with full traceability
Risk Management
ISO 14971 compliant risk analyses and monitoring
V&V Documentation
Manage Verification & Validation protocols centrally
Change Control
Automate impact assessments and approval workflows
CAPA Management
Track and document Corrective & Preventive Actions
Post-Market Surveillance
PMS plan execution and vigilance reporting
Typical Project Timeline
Regulatory Gap Analysis
ISO 13485 + MDR/IVDR assessment, review risk management, roadmap
QMS & DHF Implementation
Design Controls, Risk Management, Technical Documentation, software setup
Audit Prep & Mock Audit
Simulate Notified Body standards, correct findings
ISO 13485 Certification
Successful Notified Body audit
Start your ISO 13485 certification
Free initial consultation: We assess your starting point and create a roadmap
Free Expert ConsultationReady to revolutionize your compliance?
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