Certifications

When selecting a manufacturing partner, regulatory alignment isn’t optional — it’s essential.

ATL Medical maintains the certifications and quality systems required to support global medical device development and manufacturing. Our facilities are registered with the FDA and certified to ISO 13485, with cleanroom environments that are certified or compliant across all manufacturing sites. We adhere to Current Good Manufacturing Practices (cGMP) and maintain ITAR compliance where applicable.

These standards ensure our processes, documentation, and quality systems are audit-ready and aligned with the regulatory expectations of leading medical device OEMs.

We invite you to review our certifications and supporting documentation below.