Case Study: Watchmaker Genomics gets quality right first time with Qualio

Why Watchmaker Genomics chose Qualio to get quality right first time

Watchmaker Genomics, a Boulder, CO-based medical device company specializing in protein engineering and enzyme manufacturing, needed to establish quality right from the start as it pursued ISO 13485 accreditation. Because its products are used in CAP/CLIA laboratories, the team wanted a digital quality approach early on to manage documents, training, batch records, CAPAs, and other core quality processes in one place. To do that, Watchmaker Genomics chose Qualio’s eQMS.

With Qualio, Watchmaker Genomics created a single source of truth for document control, training, quality events, suppliers, and more, while reducing the need for heavy customization or complex validation. The system was easy to roll out across the company, helped the business scale from 10 employees to nearly 90, and supported customer confidence in its quality and compliance practices. Watchmaker Genomics says Qualio has helped it win new business and prepare for its upcoming ISO 13485 Stage 2 audit with greater confidence.

Watchmaker Genomics

Maran Sprouse

Process Development & NPD Team Lead