Leica Microsystems has announced the launch of Exalta, a smart device for reliable quality control of medical devices. Exalta integrates conventional microscopes with cameras into a connected digital inspection platform.
The quality process becomes a digital approach where manual steps are minimised. As a result, it should be less prone to errors and easily traceable.
For the medical device industry, quality problems carry serious risk, so the reliability of quality control is crucial. Exalta helps users to minimise this risk and ensure quality in an efficient way. Guided step-by-step work instructions safeguard consistent visual inspection across multiple operators in accordance with standard procedures. Data is stored during inspection and reports are generated automatically. Managers have secure access to essential information 24/7. The approval workflow allows users to efficiently track documentation with an audit trail. With Exalta, users also can be ready for 21 CFR Part 11 regulations and GxP guidelines.
Markus Lusser, president of Leica Microsystems, said: “Exalta will help to transform traditional quality control into a digitally enhanced, traceable quality control process for the medical device industry. 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."
Reinhold Pohlner, product manager, applied microscopy, Leica Microsystems, added: “To gain access to markets with the most rigorous quality standards, such as medical devices, it is imperative that these products meet the highest specifications. Exalta helps users fulfil the stringent requirements for consistent traceable quality in this field. The smart device will provide users the ability to easily follow and adapt to changing standard procedures and ever-stricter regulations.”
Medical device quality managers can establish a digitally enhanced inspection solution using Exalta. It helps them to achieve consistent quality control across multiple operators and efficient inspection and report generation, as well as be ready for regulations and guidelines.
