Overview
Quality management certification for medical device manufacturers.
Key Features
Product safety compliance
Documented design controls
Traceability
Risk mitigation
Global market entry
Certification Process
1
Initial Assessment
We evaluate your current systems and identify gaps against the standard requirements.
2
Implementation Support
Our experts guide you through the necessary changes and documentation requirements.
3
Pre-Audit Review
Comprehensive review to ensure you're ready for the formal certification audit.
4
Certification Audit
Formal assessment conducted by our certified auditors to verify compliance.
5
Certificate Issuance
Upon successful completion, your certificate is issued with ongoing support.