Since 2014, Proscia has been building software solutions for pathology and cancer research. The company recently decided to apply their software to a clinical setting to enable pathologists to work more effectively by moving from microscope-based workflows to a slide image management system that imports and reads digitized slides from multiple scanning sources, making it easier for doctors to store, retrieve, manipulate, and annotate them from any location where there is internet access.

To ensure the transition to the new market was a smooth one, Proscia needed a complete and compliant electronic quality management system (eQMS) that was cost-effective and could be implemented rapidly. After researching their options, they chose Qualio and were able to achieve Medical Device Single Audit Program (MDSAP) compliance shortly thereafter, allowing them to bring powerful software as a medical device to pathologists around the world.

The Challenge

To sell their medical device software to healthcare customers, Proscia needed a quality management system that would enable them to enforce high quality standards to ensure compliance with all relevant regulations.

Since they wanted to sell their product internationally, the company needed a solution that would help them achieve MDSAP certification thereby ensuring compliance with FDA and ISO regulations and allowing them to sell to organizations in Australia, Brazil, Canada, Japan, the European Union, and the United States.

“We needed a simple but comprehensive solution to document management for a small company that was cost-efficient, Part 11 compliant, flexible in configuration, but still easy to use and with reliable tech support,” explains Barbara Young, senior quality manager at Proscia.

With Qualio, Proscia gets a robust eQMS that has already delivered a number of benefits to the organization.

Download the Case Study: Proscia Uses Qualio to Bring High-Quality Medical Device Software to Pathologists around the World

 

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Published by Robert Fenton September 29, 2020
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