Services
Quality and Regulatory Compliance
- Creation and implementation of Quality Management Systems, compliant to USA FDA 21CFR 820, ISO 13485:2016, MDSAP, EU MDR and others, as required.
- Compilation of Regulatory Submissions including USA FDA 510k, EU Design Dossier, EU Technical File and international registrations / licenses, as applicable.
Sterilization
Sterilization Services available including Assessments and Validations for Ethylene Oxide, Gamma Radiation, Steam Sterilization and Others.
Remediation
Remediation services available for MDSAP Audit Report Nonconformances, FDA Warning Letters, FDA Form 483 Remediation and FDA Responses