We asked EvoEndo's CEO how Qualio has impacted her business
EvoEndo is the developer of a single-use gastroscope system which allows transnasal upper endoscopies to be performed without sedation or anaesthesia.
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.
EvoEndo relied on a different contract manufacturing organization (CMO) to build its initial eQMS from scratch.
But the on-premise nature of that eQMS, coupled with a significant level of paper, quickly became clunky and unfit for purpose.
CEO Heather Underwood didn't want to keep flitting between physical files and on-premise devices, and soon found that efficiency and document control were beginning to slip and hamper the company's FDA 510(k) preparations.
Reviewing and approving documents required a drawn-out process of printing, signing and scanning, and accessing vital QMS info wasn't easy.
I have a computer science background and the antiquated aspect of some of the quality tools we were using was astounding to me.
Our whole team is remote and it just wasn't working. Nobody could easily tell what was going on.
I wasn't using the system because it wasn't usable.
As EvoEndo changed to a fresh CMO, they also began to look for a purpose-built, pre-existing and cloud-based eQMS to better serve their needs.
In particular, Heather wanted to flesh out EvoEndo's internal quality management system, including elements like document control and training management without relying solely on the product-based data in her CMO's QMS.
Heather needed an intuitive, easy-to-use eQMS platform which could knit EvoEndo's operation together with that of her CMO (based in Florida) and the company's distribution partner (in Ann Arbor, Michigan).
After reviewing a string of potential vendors, it was the supportive Qualio+ offering which made Qualio stand out as Heather's partner of choice.
Initially, we didn't have anyone on the quality side.
The support Kelly and the team gave us at the beginning was great and we were really leveraging them to build out our QMS from scratch with templates and everything.
It was so streamlined, it was so efficient, they were super helpful and communicative.
That's exactly what we needed - and that's why we went with Qualio.
EvoEndo became Qualio customers in mid-2020.
As someone who'd never performed an eQMS validation exercise before, Heather was pleasantly surprised by how straightforward, simple and fun the process was.
With targeted training from the Qualio customer success team, and Qualio+ support allowing EvoEndo's new system to be quickly populated with compliant document templates, Heather could start using her new eQMS in a matter of weeks.
Heather noted a 'night and day' difference after implementing Qualio.
Core quality tasks like digital document signatures, review processes and training can now be done at a fraction of the previous time and effort, while engagement with the quality system has skyrocketed.
No-one used our old system. Everyone uses Qualio.
The UX is intuitive and everyone's used to logging in and checking their Dashboard.
Everyone's comfortable using it.
Night and day is the only way to describe it!
Heather and her team now access a complete cloud-based eQMS within Qualio, spanning:
Documents, including technical documents, the company's Design History File and more
Training management
Quality event management, including CAPAs, feedback and complaints
Design controls
To support the groundswell of activity surrounding EvoEndo's upcoming market launch, Qualio is also being used to ensure marketing materials are reviewed and approved by the EvoEndo regulatory and compliance team before going live.
As CEO, Heather has now been able to step away from day-to-day quality management as the business grows, comfortable and able to 'sleep better at night' now that her quality team has an intuitive system behind them.
I can review and sign off on documents on my phone as I travel. I can complete training or take a look at an SOP.
It's really easy and it's allowed us to grow our business.
With a connected cloud-based quality system, the company has been free to grow and pass through 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.
And crucially, EvoEndo has been able to demonstrate its quality and compliance credentials to the FDA, who cleared the company's 510(k) submission in February 2022.
With Series B funding on the horizon and the company's first market launch arriving this year, Heather believes Qualio will only deliver more value as customer activity, shipping documentation and purchasing controls are added into the company's day-to-day operations.
Qualio gives everyone a roadmap in this time when we're having to move very quickly.
Having that structure for everyone to work within is going to be essential for us to really succeed this year in getting onto the market and staying compliant.
I have only good things to say about Qualio.
