ISO · CE · FDA COMPLIANCE CONSULTING
Where Quality Commands.
Expert consulting for ISO certification, CE marking and FDA compliance — now backed by a platform that classifies your regulatory risk, tracks every audit, and manages your documentation in one place.
- Client pass rate
- 100%
- Regulatory frameworks
- 6
- Dedicated lead auditor
- 1:1
- ISO 9001
- ISO 13485
- ISO 17025
- ISO 29001
- MDR / IVDR
- FDA
Introducing the Certilance Platform
Consulting, backed by software.
Every engagement runs through a single workspace — risk classification, certification roadmaps, document control, and audit scheduling, all tracked in real time alongside your lead auditor.
The Process
Four steps to certification.
- 01
Free Consultation
We learn your business and map which frameworks apply.
- 02
Risk Classification
The platform classifies your product and regulatory pathway.
- 03
Roadmap & Documentation
We build your QMS documentation and certification plan.
- 04
Certification & Audit
Your lead auditor guides you through the certification audit.
Core Services
Consulting across every framework.
ISO Certification
Quality management systems designed to meet international standards with precision and reliability.
- ISO 9001
- ISO 13485
- ISO/IEC 17025
- ISO 29001
CE Marking
Complete Medical Device Regulation compliance support from technical files to market authorization.
- EU MDR
- EU IVDR
- EUDAMED
FDA Compliance
Navigate FDA requirements with expert guidance through registration, listing, and documentation.
- 510(k)
- PMA
- De Novo
- QMSR
Our Approach
Clear steps. Close collaboration. No unnecessary complexity.
- Medical Devices
- Industrial Manufacturing
- Oil & Gas
- Testing Laboratories
- Aerospace Suppliers
- Diagnostics
- Consumer Products
100% of engagements have reached certification
Every engagement we've taken on has reached certification — first time, no re-audits.
Certilance Consulting
6 regulatory frameworks under one workspace
ISO 9001, ISO 13485, ISO 17025, ISO 29001, MDR/IVDR and FDA — tracked from one workspace.
The Platform
Free initial consultation, honest answers
No pressure, no jargon — a straight answer on what certification requires and what it costs.
Free Consultation
One dedicated lead auditor, start to finish
One point of contact who knows your file, from kickoff through the certification audit.
1:1 Support
Every step tracked, nothing lost in email
Every document version, deadline and finding logged automatically — nothing chased over email.
Audit Tracking
Trusted across regulated industries to reach first-time certification.