Quality Management - Medical Devices

Quality Inspection is a critical business process to ensure meeting the standards and compliance aspects for manufacturers serving the Medical Industry. The process of tracking, documenting, tracing and setting an accountable system can be very costly unless your organization will harness automation.

In addition, the 21st century globalization has created new opportunities for manufacturers to become more decentralized and incorporate profitable outsourcing into their business models. However, manufacturing business processes has to be streamlined in order to gain potential benefits. The capability to manage your supply chain effectively and with less issues is a huge advantage - this is where HighQA’s Quality Management System with its flagship software product “Inspection Manager”, makes a difference.

No matter the size of your organization and supply chain, working with our system enables you to meet the standards require by Medical customers.

HighQA’s Quality Management System helps you to achieve the FDA 21 CFR Part 820, Quality System Regulation, and/or ISO 13485:2016 Medical Devices Quality Management System and record keeping requirements for our Medical Industry customers. Our system improves the productivity, consistency and accountability of your quality processes.

We pride our system on having outstanding automation and usability. The entire 2D print set of requirements (GD&T) is OCR in one click! All the requirements are digitized into an SQL database which leads to full automation of the Bill of Characteristics, First Article report and additional specific reporting as well as collecting data from CMM equipment or the shop floor is fully automated with additional applications built into our system.

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About High QA

Committed to the automation of quality assurance processes, High QA is a team of manufacturing experts with over 100 years of experience in mechanical CAD/CAM, inspection, PLM and Lean manufacturing.

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