Rethinking Clinical Evaluations: Why Flinn Partners with qtec

Clinical evaluations succeed when expertise is empowered by seamless collaboration.

They succeed when teams are aligned.
When responsibilities are clear.
When collaboration is transparent.

For medical device manufacturers, the real question is therefore not if clinical evaluations are done, but how.

Should they be handled internally, embedded within existing regulatory teams?
Or outsourced to external experts with specialized clinical and methodological expertise?

Both models are well established.
Both can deliver strong results.

Internal integration strengthens ownership and long-term alignment.
External partnership brings focused expertise, medical experience, and methodological depth.

The challenge is not choosing one over the other.
It is making either model sustainable.

This is where the partnership between Flinn and qtec begins.
Not by replacing one model.
But by strengthening how both can work together.

Meet qtec: Clinical Expertise, Delivered by People

If you’ve ever worked with external consultants, you know the difference it makes when you actually know who is doing the work.

Qtec is a regulatory and clinical consultancy supporting medical device manufacturers across quality management, regulatory affairs, clinical affairs, and post-market surveillance.

Their core focus is clinical evaluation, from systematic literature reviews to the final Clinical Evaluation Report (CER), ensuring evidence-based compliance at every stage supported by decades of medical experience.

What truly sets qtec apart is how they approach collaboration.
No anonymous delivery teams and no black-box execution.
Instead: direct contact, clear accountability, and long-term partnerships built on trust.

Or, as qtec puts it themselves: business is always done between people.

Why Clinical Evaluations So Often Get Outsourced

Did you know that clinical evaluations are among the most frequently outsourced regulatory activities?

That’s because they require:

• deep methodological expertise

• constant regulatory awareness

• significant time and coordination

Building and maintaining that capability internally is demanding.
Outsourcing, on the other hand, relieves pressure, true, but it often introduces new challenges like limited transparency, high costs, and knowledge that quietly disappears once a project is completed.

In practice, manufacturers are often left balancing two imperfect options.

Two Paths, One Platform!

This partnership is built around a simple idea: different companies need different operating models, but they shouldn’t have to compromise on visibility or control.

If you’re thinking about insourcing, here’s the elevator pitch: With Flinn, workflows become structured, searchable, and reusable. AI-supported data extraction cuts down manual work, enabling smaller internal teams to manage complex clinical evaluations more efficiently.

Insourcing, therefore, doesn’t have to mean endless headcount growth.

Or are you planning to outsource? Then the process should no longer feel like handing work over to a black box. Qtec works directly within Flinn, combining clinical expertise with a shared digital workspace. That means:

• expert-driven execution

• clearer processes

• and, for the first time, real-time visibility into what’s happening

Outsourced, without losing oversight!

One Process, Not a Patchwork

Anyone who has managed multiple vendors knows how quickly coordination becomes a job in itself.

That’s why Flinn and qtec operate as a unified solution: one process, one point of contact, and one coordinated workflow.

So what does that look like in practice?
Flinn coordinates the collaboration with qtec as part of an integrated delivery model, so customers don’t have to manage interfaces between software, consultants, and internal teams. A relief, especially for organizations handling dozens or even hundreds of clinical evaluations.

From Project Files to Organizational Memory

One question inevitably arises in traditional outsourcing models:
Where does all this knowledge actually go?

Too often, the answer is uncomfortable: it remains with the service provider.

With Flinn, that changes:
Everything qtec does within Flinn (extracted data, assessments, decisions) remains accessible to the customer. Over time, this turns individual projects into a growing, searchable knowledge base.

Less repetition, more continuity. And clinical evaluations that build on each other instead of starting from scratch.

Why qtec Is the Right Partner

At Flinn, quality always matters. But so does the way it’s delivered. Qtec brings decades of experience in clinical evaluation.
And a consistently high quality standard, combined with a steadfast commitment to personalized, in-house partnership and direct access to our senior experts.

Customers know who they’re working with: They talk to the author and stay involved.

It’s a philosophy that aligns naturally with our own approach: technology should support expertise, not hide it.

How the Workflow Adapts to You

There is no fixed setup, by design.

Some customers fully outsource clinical evaluations to qtec.
In these cases, qtec manages the full workflow within Flinn, from data searches to the documentation of results, including literature and post-market surveillance activities.

Others prefer shared responsibility models. They handle certain steps internally and hand over others.

Handover points remain flexible and can evolve over time, just like regulatory strategies do.

Built for Updates, Not One-Offs

Clinical evaluations are living documents.

Flinn supports this reality by allowing search strategies to be created once and reused indefinitely. Updates are handled by extending the search period, so there is no need to rebuild workflows from scratch.

Especially in post-market phases, this turns what used to be a burden into a manageable, repeatable process.

And What’s Next?

Today’s workflows are only the starting point:

Flinn and qtec already collaborate on joint events, shared knowledge formats, and new use cases, including the automation of trend detection in complaint data, a task that is still largely manual across the industry.

Final Thoughts

This partnership isn’t about software versus consultancy, it’s about combining clinical expertise with transparent, sustainable workflows.
Together, we share a clear ambition: turning regulatory work from reactive projects into scalable, data-driven processes.

Clinical evaluations stay expert-driven.
Processes become easier to manage.
And knowledge remains with the organizations that create it.

We’re genuinely excited to partner with qtec and to build something meaningful together!

Want to find out more? Visit qtec’s website and contact us.