Even during the midst of the COVID-19 pandemic, Qualio's remote implementation approach allowed Phil and the Bond team to be trained on, and start using, Qualio in a matter of months.
As a holistic cloud-based quality software system, Qualio provided Phil with the foundational quality management ingredients he needed, while being easy and intuitive enough to encourage business-wide engagement.
The fundamental structure is there of approvals, reviews, version control, awareness training, questionnaires.
None of that have I had to think about how to establish, because it's pre-existing.
So my time's been much better spent thinking about how we want to realize product.
With a digital quality management system in place, Phil felt he could 'ignore' and acknowledge as 'already there' what would have been manual and time-consuming QMS building blocks.
As a result, he could then use his headspace for Bond's real quality objectives: to scale, achieve ISO 13485 and IEC 62304 accreditation and hit the market.
Phil and the Bond team now rely on Qualio to provide a controlled, dedicated system for:
With a single source of truth underpinned by periodic review and version control functionality, Phil now enjoys a controlled and centralized set of quality information which is always up-to-date and compliant.
We now have a consolidated device file which reflects the development of our product.
That's a collection of controlled records within our Qualio system.
18 months ago, we didn't have anything like that to reflect on.
Perhaps most importantly, Phil has found that Qualio makes audits simpler and more straightforward in 2 key ways:
1. A single source of truth makes it easy to respond to auditor questions and retrieve requested data
2. Connecting colleagues to Qualio and assigning them as document owners encourages shared responsibility and ownership of the quality system
As a result, the Bond team breezed through its audits and achieved its ISO 13485 and IEC 62304 accreditation.
With Transform successfully launched, fresh products on the way and unshakeable quality and compliance established, Phil's work with Qualio has laid the foundation for an exciting market expansion for Bond Digital Health.