Leica Microsystems today announced the launch of Exalta, a smart device designed to deliver quality control of medical devices.
Exalta integrates conventional microscopes with cameras into a connected digital inspection platform, according to the company. The quality process becomes a digital approach that minimizes manual steps, making it less prone to errors and more easily traceable, Leica said in a news release.
For the medical device industry, Exalta provides guided step-by-step work instructions to attain consistent visual inspection across multiple operators in accordance with standard procedures. Data is stored during inspection and reports are generated automatically. The approval workflow allows users to track documentation with an audit trail. Exalta can also help users prepare for 21 CFR Part 11 regulations and GxP guidelines, the company added.
“Exalta will help to transform traditional quality control into a digitally enhanced, traceable quality control process for the medical device industry,” said Leia Microsystems president Markus Lusser in the release. “Our new smart solution for traceable microscopy will empower companies to quickly convert manual visual inspection workstations into connected digital imaging stations. This advancement can enable the streamlining of quality control processes, helping to ensure product quality, patient safety, and supply chain continuity.”