When you work in MedTech consulting, the stakes couldn’t be higher. Deadlines are tight, compliance standards are unforgiving, and one missed document can slow a project or an entire submission by weeks.
For CS Lifesciences, a medical device consultancy serving clients from startups to multinationals across the UK, Ireland, and the USA, the challenge was clear: manage documentation and regulatory submissions in a way that keeps pace with clients’ innovation while meeting rigorous ISO 13485 and FDA requirements.
The Challenge: Fragmented Tools and Friction in Collaboration
Before QuickVault, many of CS Lifesciences’ MedTech clients were working from a fragmented mix of file shares, email threads, and single-purpose tools. Controlled documents could be buried in multiple locations, creating risk every time a team needed to confirm the “current” version.
“Every extra step in tracking down a document was time not spent on moving the project forward,” says Edwin Lindsay, Principal Consultant at CS Lifesciences. “And when you’re dealing with regulatory submissions, time is everything.”
For CS Lifesciences, supporting these clients also meant working within those same scattered systems. They had to navigate inconsistent permissions, manually maintain retention schedules and audit trails, and apply metadata across multiple platforms. This translated into hours of extra work that slowed delivery, increased administrative overhead, and made it harder to keep projects on schedule.
The Turning Point: Adopting QuickVault Hub
CS Lifesciences implemented QuickVault Hub to bring order to the chaos and make it easier to collaborate with clients in a secure, centralized environment. The goal was not just to store documents. It was to manage the entire lifecycle of shared documentation in a way that supported both their internal teams and the MedTech companies they serve.
With QuickVault Hub, CS Lifesciences can now create secure, client-specific workspaces in minutes. Engineering, Quality, and Clinical teams can co-author protocols, share medical device file artifacts, and collect e-signatures in one place. There is no longer a need for FTP transfers or scattered email chains.
Version-controlled vaults with ISO 13485 and FDA-ready audit trails give clients confidence that every change is tracked. When regulators or notified bodies need access, granular, time-boxed permissions ensure they see only what is necessary, helping reviews and approvals move forward without delay.
The Game-Changer: QuickVault’s Regulatory Submission Functionality
For CS Lifesciences, the release of QuickVault’s Regulatory Submission functionality of its eQMS solution was transformative. What once took days of cross-checking and manual organization now happens with a single click.
“The submission workspace auto-organizes every document into the correct FDA and ISO 13485 folders, flags missing artifacts, and locks final versions,” Edwin explains. “We can assemble a clean, inspection-ready dossier in hours instead of days.”
The standout capability? A controlled “workspace-to-e-sign” workflow that moves a document from draft, through parallel review, to locked and validated status, without exports or re-uploads. The result: turnaround times have been cut nearly in half.
See how QuickVault can help your team work faster and stay compliant by booking your personalized demo now →
The Results: Faster, Cleaner, More Confident Compliance
With QuickVault Hub and the Regulatory Submission functionality working in tandem, CS Lifesciences has transformed how they, and their clients, approach compliance:
- 50% reduction in document preparation time for audits and submissions.
- Multi-party review cycles cut from weeks to days, enabling earlier submission readiness.
- Elimination of rogue document copies thanks to automated version control and policy-driven retention.
- Proactive compliance for both CS Lifesciences and their clients, with complete, traceable dossiers ready before anyone asks.
Or as Edwin sums it up:
“QuickVault Hub pays for itself the moment a client or auditor asks for a document and you can produce the latest, fully-tracked version in seconds.”
Looking Ahead
For CS Lifesciences, QuickVault isn’t just a tool, it’s a new way of working. By centralizing and automating critical compliance workflows, they’ve freed their team to focus on what matters most: helping MedTech innovators bring safe, effective products to market faster.
And with regulatory demands continuing to evolve, that shift from reactive document hunting to proactive, always-ready compliance provides the competitive edge their clients need.
