Medical device QMS software

Integrate quality, reliability and patient safety into your product lifecycle.

Embed automatic, intuitive regulatory compliance

Achieving unshakeable quality and compliance is vital for your business to bring a medical device to market – and keep it there. Our medical device QMS software is designed to streamline, centralise and simplify your regulatory processes, easing your compliance burden and slicing your time to market.

Modernise and strengthen your quality management system

Integrate quality management with product lifecycle, safety and risk management processes to build a strong, collaborative QMS for medical devices.

Faster, simpler ISO 13485 compliance

Our ISO 13485 software system gives you the tools and functionality for a robust, compliant medical device operation.

Create a culture of reporting and safety

Make quality and compliance the responsibility of everybody with a digital medical device QMS that everyone accesses and supports.

Control and protect reputation and brand

Make your third-party relationships even stronger with targeted control.

Help anticipate and prevent problems and issues

Analyse your quality process activities and anticipate risks, turning them into opportunities.

Achieve and demonstrate compliance with MHRA and FDA regulations and other international standards, including:

MDR

Stay on track with the MDD’s replacement regulation - the biggest change to EU medical device regulations in the past 20 years.

Stay on track with the MDD’s replacement regulation - the biggest change to EU medical device regulations in the past 20 years.

Ensure adherence to the new IVDR which comes into effect in 2022 and will apply to all in vitro medical devices.

ISO 13485

Achieve ISO 13485 compliance while accelerating time to market and mitigating future risk.