How Qualio empowered Bond Digital Health with an SaMD QMS from scratch
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Bond Digital Health provides medical software which digitizes raw data from in vitro diagnostic devices such as COVID-19 lateral flow tests.
Bond's Transform SaaS platform is used by point-of-care diagnostic providers for real-time capture and storage of patient data, making ISO 13485 and IEC 62304 compliance a crucial component of Bond's operation.
Since the company also processes thousands of patient records each day, GDPR and HIPAA compliance were also identified as vital quality and regulatory targets.
Like any start-up, Bond Digital Health began with no quality management system - but ambitions of becoming a quality-centric, quality-culture-driven organization guided by defined processes.
Those quality cultural aspects - accepting having to follow process, establish process, communicate process, evidence the existence of those things - didn't really exist.
Since he was tasked with building the company's QMS and helping bring Bond's software system to market, Quality Manager Phil Cooley wanted to quickly and easily establish compliant, documented processes for core quality management activities, like document control, without the time-consuming effort of manually building processes and encouraging colleagues to follow them.
Phil recognized that turning to an electronic quality management system (eQMS) early in the company's life would act as a vital shortcut - not only giving Bond a ready-made quality management structure at a stroke, but also offering a centralized single source of truth for Phil's colleagues to access, work from and store objective evidence and data for Bond's pathway to market.
I felt we would do a lot better to sidestep the effort required to establish processes.
Why try to find workarounds and convoluted processes to achieve that using multiple different systems, when there are pre-existing systems on the market that fit that bill?
There's then less effort required in that area - and more can be focused on product realization.
Since there was no pre-existing QMS, Phil was free to search for the best possible eQMS vendor without any constraints or legacy systems to consider.
Rather than using current processes to benchmark for a suitable platform to accommodate them, Phil worked in the opposite direction and began looking for an easy-to-use intuitive eQMS platform which would offer and enable processes for Bond's start-up phase.
There are other eQMS providers that are very well-established, very technically capable and able, but not particularly accessible to organizations that don't have the fundamental basics in place.
Qualio is not overly complicated. That's what nudged me towards Qualio as a much more accessible interface, that gave us those foundational aspects of a quality system in a way that people could actually get behind.
Phil was drawn to Qualio's strengths of ease of use, rapid set-up, intuitive UX and large start-up customer portfolio.
Qualio was pinpointed as the best match for Bond's requirements, and Bond Digital Health became Qualio customers in mid-2020.
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.
