Medical Devices

Facing growing compliancy demands

Today, the Medical Devices industry faces a growing amount of regulations like the FDA’s 21 Cfr Part 820 and Medical Devices Directive 93/42/EEC. Moreover, the FDA (Food and Drug Administration) and EMA (European Medicines Agency) are increasingly performing audits to verify whether all requirements are respected.
Using ISO 13485, quality management professionals have to keep up with these evolutions. Flawless document management, optimal trainings, efficient validations and other aspects are more important than ever. In this complex landscape, a top-notch software platform has become crucial for meeting all QMS requirements. And that’s where Neomatics comes in.

An efficient software solution to meet QMS requirements

Neomatics delivers a versatile, easy-to-use and highly efficient software package that creates the shortest route to full compliancy. It consists of eight products, each of them covering a specific quality management aspect: Document Management, Events & CAPA, Training, Audit, Validation, Change Control, Suppliers, and Equipment. All of these products seamlessly interact, though each of them can also be deployed separately.

Our products are SharePoint-based and therefore very easy to integrate. This will save you lots of budget and time. Certainly if you compare them with fully tailored technologies, which are often more rigid: they’re harder to adapt to changing demands, their maintenance costs can get pretty high, each change requires hours of development, and so on.

Choosing Neomatics means choosing smooth integration and user-friendliness. Once up and running, our solutions will significantly reduce risks and ensure that all requirements are met. Needless to say, their efficiency will enable you to save costs in your day-to-day quality management.

Discover our solutions now

Eager to find out more? Discover all of our products here.
Want to learn how it works? Ask for a demo or contact us.
We’ll gladly listen to your needs, in order to propose the right solutions.