As an FDA-regulated company, Swan Valley Medical (SVM) is required to show objective evidence to support all processes from design and development through post-market evaluation.
“Swan Valley Medical designs, manufactures, and distributes patented, single-use, urology instruments, and accessories to manage the symptoms of urinary retention or incontinence. We are regulated by the FDA and are certified to ISO 13485:2016. This requires us to maintain a system and detailed records to support our operations and exceptional quality standards,” said Swan Valley Medical’s Director of Quality Assurance and Regulatory Affairs, Michelle Potvin.
With design and manufacturing operations in Denver, CO, and suppliers across the U.S. and Taiwan, the challenge was—how to improve product information management synchronization across a globally dispersed supply chain and organize evidence of compliance to avoid costly penalties.
Like many medical device companies, SVM was burdened with inefficient, manual, paper-based quality management processes that created compliance risk issues due to their inability to easily find critical documentation. Because information was typically in paper form it was prone to being misplaced, damaged, or inadvertently thrown away.