Get Your ISO 13485-Compliant QMS in Just 6 Weeks
123Certify is a turnkey service for medical device companies who want to move fast—without compromising compliance.
What’s Included:
- Week 1–2: Process assessment, needs discovery, and roadmap
- Week 3–4: Full QMS documentation drafting and customization
- Week 5: Internal audit prep + team training
- Week 6: Final review and certification readiness check
Choose Your Package:
| Package | Price | What’s Included |
|---|---|---|
| Standard | €20,000 | Full QMS, templates, remote support |
| Premium | €25,000 | Includes audit-prep training & live reviews |
| 123Certify+ | from €30,000 | Includes a reserved ISO 13485 certification slot with QSInternational |
Bonus:
With 123Certify+, we’ll not only build your QMS—we’ll also coordinate your ISO 13485 certification through our partner certification body QSInternational, including:
- Pre-scheduled certification audit
- Full submission package
- Support before, during, and after audit
No more chasing deadlines or guessing what auditors want. We handle the hard part, so you can focus on innovation.
Why Work With Us?
✔ 15+ years combined regulatory experience
✔ AI-supported tools for documentation and gap assessment
✔ Fast-track results, startup-friendly pricing
Ready to Move Fast—Without Breaking the Rules?
Build and Certify Your QMS with 123Certify
Contact us now | 📞 +49 170 5275221 | +41 79 914 84 34