SERVICES

CERTIFICATION

ISO 13485 Medical devices
Quality management systems
Requirements for regulatory purposes

SERVICES

TRAINING

ISO 13485:2016
CE Marking
510(k) Fundamentals

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TESTING

Biomechanical Testing
Finite Element Analyze

SERVICES

CONSULTANCY for US Regulations

510(k) Submissions
Product Registrations
U.S. Agent Services

SERVICES

CONSULTANCY for EU Regulations

Design Dossiers Documentation
Technical File Documentation

SERVICES

CONSULTANCY for Clinical Evaluation

Clinical Evaluation
Post Market Clinical Follow-Up Study
Clinical Trial