Regulation

Our technical and regulatory knowledge enables us to deliver safe and effective products.

As a 100% medical focussed company, Pix naturally works in accordance with all relevant regulatory frameworks and industry standards.

 

Risk Management Approach

Throughout our development process we identify, assess and score risks. Each assessment is conducted by experts in their respective fields, and is constantly updated throughout the product development lifecycle – allowing Pix to develop safer and more reliable products.

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Human Factors

In all of our projects we ensure the end users and key stakeholders are involved as early as possible and throughout development. Whether it’s during initial discussion with patients or user trials, we use human factors engineering to ensure our apps are effective, our devices are safe, and the user’s data is easy to understand.

 

Safety at Heart

In order to ensure safety, Pix Medical are experienced in building system architectures that minimise the possibility for error. By focussing on reducing risk from the outset, we are able to speed up the route to CE Mark or FDA approval.

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Certification

All our work is done in accordance with ISO-13485:2016. We are currently building an internal quality management system in order to obtain ISO 13485 certification later this year. All our software development is done in accordance with IEC 62304:2006 medical software lifecycle.

We’re comfortable working within regulatory frameworks.

We’d love to hear about your project and help make it a reality