Certifications

To ensure compliance with our standards, internal and external audits of our quality and regulatory systems are conducted. Our notified bodies and quality system registrars in the EU conduct annual independent assessments of our ISO-certified manufacturing and contract sterilization facilities, as well as our facilities for medical specialties, to verify compliance with standards. Each year, HA2 undergoes numerous assessments by notified bodies at our various facilities, as well as additional audits by many of our customers who are manufacturers themselves.