Quality & Compliance
Quality & Certifications
We maintain quality systems and certifications aligned with international medical device standards.
Certification snapshot
Standards that support trust
Certification information is intended to summarize applicable quality and compliance programs.
ISO 13485
Quality management system for medical devices.
CE Mark
Conformity with applicable EU medical device requirements.
FDA Registration
Establishment registration where applicable.
Requirement review
Product and regulatory requirements are reviewed before a solution moves forward.
Documented controls
Quality records and traceability are maintained across the product lifecycle.
Ongoing oversight
Continuous review keeps quality systems aligned with current compliance expectations.
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