Qualio Case Studies Empowering Bond Digital Health with a Quality Management System from Scratch

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	Empowering Bond Digital Health with a Quality Management System from Scratch Qualio

Empowering Bond Digital Health with a Quality Management System from Scratch

Qualio

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
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. Read More
About 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. Read More
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. Read More Log in to view content
Contents

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

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.

About 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.

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.

Impact #1	With Qualio's eQMS, Bond Digital Health was able to establish a quality management system from scratch, without the time-consuming effort of manually building processes. The system provided a centralized single source of truth for the team, making it easier to access, work from, and store objective evidence and data. This not only improved efficiency but also ensured compliance with ISO 13485, IEC 62304, GDPR, and HIPAA. The system also made audits simpler and more straightforward, as it was easy to respond to auditor questions and retrieve requested data. Furthermore, connecting colleagues to Qualio and assigning them as document owners encouraged shared responsibility and ownership of the quality system. As a result, the team breezed through its audits and achieved its accreditation. With a digital quality management system in place, the company was able to focus on its real quality objectives: to scale, achieve accreditation, and hit the market.

Impact #1

With Qualio's eQMS, Bond Digital Health was able to establish a quality management system from scratch, without the time-consuming effort of manually building processes. The system provided a centralized single source of truth for the team, making it easier to access, work from, and store objective evidence and data. This not only improved efficiency but also ensured compliance with ISO 13485, IEC 62304, GDPR, and HIPAA. The system also made audits simpler and more straightforward, as it was easy to respond to auditor questions and retrieve requested data. Furthermore, connecting colleagues to Qualio and assigning them as document owners encouraged shared responsibility and ownership of the quality system. As a result, the team breezed through its audits and achieved its accreditation. With a digital quality management system in place, the company was able to focus on its real quality objectives: to scale, achieve accreditation, and hit the market.

Benefit #1	Bond Digital Health was able to implement Qualio's eQMS in a matter of months, even during the COVID-19 pandemic.
Benefit #2	Qualio's eQMS provided a centralized single source of truth for Bond's team, improving efficiency and compliance.
Benefit #3	Using Qualio's eQMS, Bond Digital Health successfully achieved ISO 13485 and IEC 62304 accreditation.

Benefit #1

Bond Digital Health was able to implement Qualio's eQMS in a matter of months, even during the COVID-19 pandemic.

Benefit #2

Qualio's eQMS provided a centralized single source of truth for Bond's team, improving efficiency and compliance.

Benefit #3

Using Qualio's eQMS, Bond Digital Health successfully achieved ISO 13485 and IEC 62304 accreditation.

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Overview

Empowering Bond Digital Health with a Quality Management System from Scratch

Operational Impact

Quantitative Benefit