Quality at Affinity begins at the design stage. By designing products to reduce operator dependence and labor content, quality is enhanced.In addition to using validated processes throughout the manufacturing cycle, Affinity performs 100% electrical testing and inspection before any product leaves our plant.
Dedicated to Quality
Affinity is an organization dedicated to quality in everything we do. Affinity’s reputation for quality is evidenced by it’s ongoing partnership with nearly every major medical OEM manufacturer.
Affinity is ISO 13485-2003 registered through BSI, is an FDA Registered Medical Device Manufacturer and offers CE marking under the Medical Device Directive.