'Firing on all cylinders' and saving lives with a medical device eQMS

Who are Zalgen Labs?
Frederick, MD
Company size
Medical device/SaMD

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Zalgen Labs manufacture diagnostic kits for the detection of deadly diseases, from Lassa and Ebola to SARS-CoV-2.

Their diagnostic division spun out of a larger predecessor in 2016, and needed their own quality management system to operate.

The challenge

The company's formation from a larger, pre-existing company created an unusual inverted start-up dynamic: a team of fewer than ten staff serving around thirty separate medical device products to a handful of dedicated research customers in West Africa.

Their parent company's complex, paper-based QMS couldn't be easily translated into Zalgen Labs because of their much smaller headcount.

We had full-blown SOPs, multiple forms, work instructions... it was overload. We were at our limit.

Even in our old parent company with thirty heads, it was crazy. It took dozens of people to manage it.

— Matt Boisen, Director of Diagnostics Development, Zalgen Labs
The solution

Matt knew that an electronic quality management system (eQMS) wouldn't only give Zalgen Labs an agile and efficient system that could be easily run by a small team.

It would provide a more nimble, scalable system that could more easily keep up with regulatory developments and the latest best practice.

Matt and the Zalgen team homed in on Qualio for 3 reasons:

1) Qualio's competitive, value-based pricing fit Zalgen's budget

2) Qualio's training functionality was identified as the most mature on the market

3) Qualio's customer support, with strong US presence, was the most comprehensive, with Qualio+ offering the perfect solution for migrating and digitizing Zalgen's complex document stack

The big challenge with a legacy system was sorting through what we already had that was correct, what we didn't have - the minor and major gaps - and what we weren't doing correctly and needed to fix.

— Matt Boisen, Director of Diagnostics Development, Zalgen Labs

Zalgen Labs went live with Qualio in June 2022.

The results

Qualio gave Zalgen Labs an agile, paperless framework for managing quality more effectively and, in Matt's words, 'firing on all cylinders'.

Headcount expansion, including a director-level quality hire, was mitigated, delivering immediate return on investment.

With close support from the Qualio+ team, Matt could adapt and optimize Zalgen Labs' stack of over 100 documents as it was digitized and fed into Qualio.

And Qualio Design Controls has given Matt and the team a central area for boosting control of device risks and building fresh Design History Files, taking the company a big step closer to their next objective of preparing key devices for CE marking and 510(k) submissions.

Zalgen Labs are now approaching the tipping point of maximizing their Qualio ROI, positioning themselves for their next phase of growth with a compliant eQMS firmly in place.

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