EvoEndo's Transformation with Qualio's eQMS

Technology Category

Cybersecurity & Privacy - Security Compliance
Infrastructure as a Service (IaaS) - Cloud Databases

Applicable Industries

Education
Electronics

Applicable Functions

Procurement
Quality Assurance

Use Cases

Leasing Finance Automation
Visual Quality Detection

Services

Testing & Certification
Training

The Challenge

EvoEndo, a medical device company, was facing challenges with its existing electronic Quality Management System (eQMS). The system, built by a different contract manufacturing organization (CMO), was on-premise and heavily reliant on paper, making it clunky and unfit for purpose. The company's CEO, Heather Underwood, found that efficiency and document control were slipping, negatively impacting the company's FDA 510(k) preparations. The process of reviewing and approving documents was time-consuming, involving printing, signing, and scanning. Accessing vital QMS information was also difficult. As EvoEndo transitioned to a new CMO, they began to search for a pre-existing, cloud-based eQMS that could better meet their needs. Heather wanted to enhance EvoEndo's internal quality management system, including document control and training management, without solely relying on the product-based data in her CMO's QMS.

About The Customer

EvoEndo is a medical device company based in Centennial, CO, with 1-10 employees. The company develops a single-use gastroscope system that allows transnasal upper endoscopies to be performed without sedation or anesthesia. As a Class II 510(k) medical device, EvoEndo's product means the business and its outsourced contract manufacturing organization must meet the requirements of both ISO 13485 and FDA 21 CFR 820. The company was in the process of transitioning to a new contract manufacturing organization and was looking for a more efficient and effective electronic Quality Management System.

The Solution

Heather sought an intuitive, easy-to-use eQMS platform that could integrate EvoEndo's operations with her Florida-based CMO and the company's distribution partner in Michigan. After reviewing several potential vendors, Heather chose Qualio for its supportive Qualio+ offering. EvoEndo became a Qualio customer in mid-2020. Despite never having performed an eQMS validation exercise before, Heather found the process straightforward, simple, and enjoyable. With targeted training from the Qualio customer success team and Qualio+ support, EvoEndo's new system was quickly populated with compliant document templates, enabling Heather to start using her new eQMS within weeks.

Operational Impact

The implementation of Qualio's eQMS has brought about significant operational improvements for EvoEndo. Core quality tasks such as digital document signatures, review processes, and training can now be completed with less time and effort. Engagement with the quality system has significantly increased. The company now has a complete cloud-based eQMS within Qualio, covering documents, training management, quality event management, and design controls. Qualio is also being used to ensure marketing materials are reviewed and approved by the EvoEndo regulatory and compliance team before going live. As a result, Heather has been able to step back from day-to-day quality management as the business grows, confident that her quality team has an intuitive system supporting them. The company has been able to grow and secure Series A funding without compromising on compliance. New team members can be onboarded and trained quickly, and quality information can be shared and accessed at the touch of a button from a single source of truth.

Quantitative Benefit

EvoEndo's FDA 510(k) submission was cleared in February 2022.
The company successfully passed through Series A funding without compromising on compliance.
New team members can now be onboarded and trained quickly.