Technology Category
- Cybersecurity & Privacy - Security Compliance
- Platform as a Service (PaaS) - Application Development Platforms
Applicable Industries
- Buildings
- Healthcare & Hospitals
Applicable Functions
- Quality Assurance
Use Cases
- Predictive Quality Analytics
- Visual Quality Detection
Services
- Testing & Certification
- Training
About The Customer
Bond Digital Health is a start-up company based in Cardiff, Wales, with a team size of 10-49 employees. The company operates in the Software as a Medical Device (SaMD) industry, providing medical software that 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. This makes ISO 13485 and IEC 62304 compliance a crucial component of Bond's operation. The company also processes thousands of patient records each day, making GDPR and HIPAA compliance vital quality and regulatory targets.
The Challenge
Bond Digital Health, a medical software provider, was faced with the challenge of establishing a quality management system (QMS) from scratch. As a start-up, the company had ambitions of becoming a quality-centric, quality-culture-driven organization guided by defined processes. Quality Manager Phil Cooley was tasked with building the company's QMS and helping bring Bond's software system to market. He wanted to 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. The company also processes thousands of patient records each day, making GDPR and HIPAA compliance vital quality and regulatory targets. Phil recognized that an electronic quality management system (eQMS) would act as a vital shortcut, providing a ready-made quality management structure and a centralized single source of truth for his colleagues.
The Solution
With no pre-existing QMS, Phil was free to search for the best possible eQMS vendor without any constraints or legacy systems to consider. He began looking for an easy-to-use intuitive eQMS platform which would offer and enable processes for Bond's start-up phase. 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 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.
Operational Impact
Quantitative Benefit
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