Medical Device Company Passes ISO 13485 Audit with Zero Non-Conformances
The Challenge
A growing Class II medical device manufacturer needed ISO 13485:2016 certification as a prerequisite for FDA 510(k) submission. The company had tripled its workforce in 18 months but had never operated under a formal quality management system. Documentation was inconsistent, design controls were ad hoc, and there was no CAPA process. With investor pressure to reach market within 9 months, every week of delay had direct financial consequences.
Our Approach
Performed an end-to-end assessment of the existing quality practices against ISO 13485:2016 and FDA 21 CFR Part 820, identifying 62 gaps across 8 critical process areas.
Designed a fit-for-purpose QMS architecture that met both ISO 13485 and FDA requirements simultaneously, avoiding the need for costly rework during 510(k) preparation.
Built a complete Design History File (DHF) framework with design input/output controls, verification & validation protocols, and design review stage gates.
Implemented a risk management process per ISO 14971, including a product-level risk management file with hazard analysis, risk evaluation, and residual risk assessment.
Established a CAPA system with root cause analysis methodology (8D framework), effectiveness verification, and trend analysis capabilities.
Trained 22 employees across production, engineering, and quality on the new QMS, with role-specific competency assessments.
The Results
Achieved ISO 13485:2016 certification with zero non-conformances — no majors, no minors.
Built a dual-purpose QMS that satisfied both ISO 13485 and FDA 21 CFR Part 820 requirements.
FDA 510(k) submission completed 3 months after certification, directly leveraging the ISO 13485 QMS documentation.
Design control process reduced product development cycle time by 25% through structured stage-gate reviews.
First CAPA processed and closed within the new system within 30 days of go-live, demonstrating immediate system effectiveness.
100% employee training completion with documented competency verification.
“Exceleor didn't just help us check a box — they built a quality system that our FDA consultant said was the most organized 13485 implementation she'd reviewed. Zero non-conformances on the first audit was something we honestly didn't think was possible for a startup.”
Ready to Achieve ISO Certification?
Schedule your free consultation today and discover how we can help you implement ISO standards efficiently and effectively.