Medical DevicesISO 13485:2016FDA 21 CFR 820

Medical Device Company: ISO 13485 & FDA Readiness from Zero

Startup with zero quality infrastructure achieved ISO 13485 certification and FDA 510(k) acceptance — launching their first product on schedule.

9 months engagement Exceleor

1st Attempt

Certification

Accepted

FDA Submission

On Schedule

Product Launch

ZERO

DHF Findings

The Challenge

A startup medical device company needed ISO 13485 certification and FDA 510(k) readiness before their first product launch. Zero existing quality infrastructure.

Venture-backed startup with $4M Series A — certification was a condition of their Series B

No quality management system, no SOPs, no design history file

Product launch deadline tied to investor milestones — could not slip

FDA submission required completed design history file with full V&V documentation

Team of 25 engineers with deep technical expertise but no regulatory experience

Our Approach

Built the entire quality management system from the ground up, integrating ISO 13485 requirements with FDA 21 CFR 820 expectations from day one.

Phase 1: QMS Architecture & Design Controls (Months 1-3)

Designed the quality management system to simultaneously satisfy ISO 13485 and FDA 21 CFR 820. Established design control procedures and began retroactively building the design history file from existing engineering documentation.

Phase 2: Risk Management & CAPA (Months 3-5)

Implemented ISO 14971 risk management process. Conducted design FMEA and process FMEA. Established CAPA system, complaint handling procedures, and adverse event reporting framework.

Phase 3: Validation & Regulatory Prep (Months 5-7)

Executed design verification and validation protocols. Completed biocompatibility testing documentation. Prepared 510(k) submission package including substantial equivalence analysis and performance data.

Phase 4: Audit Readiness & Certification (Months 7-9)

Conducted pre-certification audit. Trained all staff on QMS procedures. Coordinated ISO 13485 certification audit while simultaneously finalizing FDA submission.

Results & Impact

Achieved ISO 13485 certification on the first attempt with zero findings. FDA 510(k) submission accepted. Product launched on schedule.

ISO 13485

First-Attempt Pass

Certified with zero non-conformances — auditor commended the design control implementation

FDA 510(k)

Accepted for Review

510(k) submission accepted by FDA with no Refuse to Accept issues

Product Launch

On Schedule

First product entered the market on the original investor milestone timeline

Series B

Secured

ISO certification and FDA acceptance enabled successful $12M Series B fundraising

Additional Outcomes

Design history file completed with zero findings during audit

Established scalable QMS supporting 5 future product lines

All 25 team members trained and competent on quality procedures

Risk management file accepted by both notified body and FDA

Post-market surveillance system operational before product launch

“As a startup, we had zero quality infrastructure and a hard deadline. They built our entire QMS, got us certified, and prepared our FDA submission — all without delaying our product launch by a single day.”

CEO

Medical Device Startup