Great question Samiha!

In my opinion, when transferring design control and standards to any contract manufacturer, especially in medical device production, companies must consider several critical issues or limitations to ensure compliance and quality. First, quality control consistency is critical. Contract manufacturers may not have the same standards as the company. Having clear, mutually agreed upon criteria along with regular audits is extremely important. Ensuring regulatory compliance is also important, particularly regarding ISO13485 which we've learned about, and often necessitates training and/or certification checks. Protecting intellectual property also requires strict confidentiality agreements to protect proprietary designs and ideas. Addressing these factors and more allows firms to maintain their product quality and regulatory adherence, protecting them from potential audit findings.