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One of the aspects of my job here at Affinity that I really enjoy is participating in audits. I am the management representative and the contact person when customers, notified bodies, federal or state agencies want to schedule an audit.
Affinity Medical is FDA registered and certified to ISO13485:2003. Our ISO registrar, BSI, audits our quality system twice a year to ISO 13485. We usually have at least one customer audit per month and we perform internal audits each quarter. Each audit is an opportunity to learn and challenge our systems. Having a robust quality system makes us a better partner for our customers.