Medical Certifications

REGULATORY APPROVAL AND CERTIFICATIONS

• FDA Registered
• ISO 13485:2003 certified
• CMDCAS (Canada) certified
• JAPAN accreditation as foreign manufacturer
• 510(k) and PMA device experience
• ISO 13485 certified backup offshore facilities with identical equipment
• Oscor Quality System is approved by most CRM and medical device companies
• Manufacture according to directives 93/42/EEC and 90/385/EEC

To request a copy of certificates please email: regulatory@oscor.com