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Upgraded Dual ISO Certifications

Elite Biomedical Solutions Upgrades Their Dual ISO Certifications

Elite Biomedical Solutions, a manufacturer of new medical replacement parts and repair services, recently upgraded their dual certifications to ISO 9001:2015 and ISO 13485:2016 standards.

Elite Biomedical Solutions has been ISO 9001:2008 and ISO 13485:2003 since 2016.  ISO 9001 is the world’s most recognized quality standard for a company’s (QMS) Quality Management System.  ISO 13485 specifies requirements for an organization’s ability to consistently meet customer and regulatory requirements applicable to medical devices and related services.

Elite Biomedical Solutions is also an FDA Registered company and adheres to the FDA’s 21CFR: 820 requirements for the healthcare industry.  We take this responsibility as a healthcare company very seriously to strictly comply with the FDA’s requirements and standards. 

Company President and Co-owner Jeff Smith said “All of these great accomplishments are a testimony of the “care and passion” of the Elite team.”  They understand the criticality of patient safety and make it their responsibility each and every day.

“Shielded by Elite”, it is our goal and commitment to providing the highest quality new replacement parts, re-certified parts, and repair services to our customers.