Certifications

Certifications

ISO 13485:2016

Requires a quality management system that consistently meets or exceeds regulatory stipulations regarding medical device production. Regular audits of Chalgren’s quality system are managed by BSI America.

Certifications

FDA 510(k)Pre-market Approval

Chalgren products undergo a comprehensive review process by the FDA before being released to the open market. Chalgren’s quality system is also audited by the FDA on a regular basis.

Certifications

Health Canada SOR/ 98-282 Establishment License

Chalgren meets and exceeds all requirements for licensure in Canada pursuant to Section 45 of the country’s Medical Device Regulations.