Hi All, I'm just learning about quality systems and regulations and I'm hoping you can help me understand the difference between ISO 13485 and 21 CFR 820. Is this an accurate way to state the similarities/differences? "Based on ISO 9001, ISO 13485 is an international standard that places emphasis on management reviews, process and design control in manufacturing, documentation, and the review of corrective actions and preventative actions (CAPA). Applicable only for products made in or imported to the United States, 21 CFR 820 is a more stringent requirement that is similar to ISO 13485 with more of a focus on monitoring and measuring the performance of products, labeling, and traceability." Thanks in advance!!