CryoStasis is a Canadian MedTech startup developing advanced preservation media, supported by specialized temperature-controlled hardware, for long-term, subzero unfrozen stem cell storage.
From their inception, documentation integrity, version control, and traceability has been of utmost importance to directly support future regulatory submissions and product confidence.
When Mechanical Systems Engineer Tarek Issa joined the company, he was responsible for hardware development and building the design history file and implementing quality documentation practices.
At the time, CryoStasis relied on OneDrive, Excel, Word, and PDFs to manage documents. These tools worked while the product was early in development, but as volume and complexity grew, maintaining alignment became increasingly difficult.
“We realized we were spending time just trying to keep our documentation tools in sync, rather than using them to support development.”
The Challenge
The need for change became clear when multiple team members unknowingly worked from outdated documents. While the immediate issue was resolved, it exposed the risk of inconsistencies compounding over time, particularly as design work accelerated.
At the same time, design controls and risk analysis were being managed in spreadsheets. Updating a single risk element meant manually retracing connections across related hazards and design outputs. This approach became time-consuming and increased the likelihood of errors.
CryoStasis realized it was time to switch to a purpose-built system that optimized and improved their operations, rather than hindered them.
During the evaluation of QMS platforms, CryoStasis found that many systems were either built for large organizations with complex configuration requirements or handled only document storage, requiring a separate tool for design controls. Neither path supported the needs of a lean team with growing documentation and engineering requirements.
“We needed a system where everything was connected—documentation and design controls together, not split across different tools.”
The Solution
CryoStasis selected QuickVault as their purpose-built solution because it offered the structure they needed without the overhead of a large enterprise QMS. The all-in-one system provided a single environment for document control, design controls, and risk analysis, and it was approachable for team members with different levels of QMS experience.
Key factors in the decision to choose QuickVault included:
- Integrated QMS and design control capabilities
- Pre-validated environment that did not require internal IT validation
- Practical, easy-to-adopt interface and workflows
CryoStasis began with a guided trial to understand how QuickVault aligned with their documentation and approval processes. Once the team was comfortable, the system was reset and transitioned into full production use.
“In under two months, we were using QuickVault efficiently across the entire team.”
The Results
Document retrieval became faster and more consistent after implementing QuickVault. Search, tags, and filters made it easier to locate the correct version of a file, reducing time spent navigating folders or confirming which document was current.
Linking related documentation was a meaningful improvement for the CryoStasis team. Instead of manually tracking references across files, team members could open a document and immediately see the items connected to it, supporting clearer decision-making and more efficient collaboration.
Review and approval workflows also progressed more smoothly. Notifications helped the team maintain momentum without requiring follow-up, and version control and audit trails provided clarity into how documents had evolved.
“QuickVault saved us time, reduced rework, and removed a lot of the stress around version control.”
Looking Ahead
Thanks to QuickVault, CryoStasis has created design history files for multiple products and expects to expand its portfolio.
The team plans to use QuickVault’s design control and regulatory capabilities to demonstrate compliance with ISO 13485 audits and prepare documentation packages for future FDA submissions, while continuing to rely on the platform for document management and traceability as development progresses.
“QuickVault is a complete QMS system. It has everything you need—from documents to design controls, training, and quality events. The fact that it’s pre-validated is a big plus for startups. It’s simple, easy to adopt, and gives you all the tools you need.”
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