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MoniDose - Case study

 MoniDose is an early stage startup developing innovative solutions in their field.

Case study

MoniDose's regulatory journey

The challenge

When MoniDose started their journey 14 months ago, regulations were their biggest concern. They felt confident in their product vision and business direction, but regulatory compliance created uncertainty. Missing early design inputs linked to standards or regulations could have caused costly redesigns later—something their team couldn’t afford.

How Entries helped

Lean Entries gave Monidose more than an introduction to regulatory principles. It ensured they didn’t miss crucial design inputs tied to standards and requirements—information that would have been extremely difficult to implement retroactively.

Using Entries raised their confidence significantly, helping them verify that all key regulatory foundations were covered. It also helped them understand the need for dedicated expertise. As a result, Monidose hired a regulatory specialist to take ownership of compliance.

Through Business Tampere’s support, they also received 5 hours of regulatory consulting from Aurevia, which complemented the clarity and structure provided by Entries—and they continue to rely on Aurevia’s expertise today.

In addition to establishing a solid regulatory foundation early on, MoniDose has already demonstrated the kind of focused momentum seen in strong healthtech startups. Their intelligent medication dispensing solution is gaining recognition in Finland and beyond, supported by a clear market need and a scalable product vision. MoniDose has also attracted notable early stage investors — including healthtech angels Leena Niemistö and Risto Kalliainen — further validating their direction and reinforcing confidence in their efficient path toward market entry.

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Results

    • Strong confidence that regulatory requirements and design inputs were covered
    • Ability to demonstrate compliance clarity to investors
    • A more focused regulatory strategy, reinforced with internal and Aurevia support
    • A smoother path toward compliance without costly redesign or rework

 What the customer says 

“As a startup our greatest challenge 14 months ago was regulations. We were confident about everything else, but really worried about regulatory compliance. What Entries provided was not just about learning the principles but making sure we don't miss design inputs that are drawn from regulations and standards, because they would've been hard to implement in our design at any later point. With the help of Entries we lifted our confidence substantially on having everything covered.”

“Entries helped us understand that we need regulatory expert help and proper resources. We hired a young and smart regulatory specialist, who took charge. We were also lucky to receive free 5 hours of regulatory support from an Aurevia consultant, paid by Business Tampere, and we continue to use their expertise today. I want to emphasize that Entries was game‑changing in this process."

Who Entries is for and why it is invaluable

According to MoniDose:

  • “Entries is for any startup like us who does not have background knowledge on regulations.”
  • “It has helped us also in convincing our investors that we're on top of compliance. They have commended us for the level of clarity we express in our regulatory strategy.”
  • “There's no other tool we know of that you could replace Entries with, and we have spent time scanning all types of regulatory tooling in addition to crafting our own eQMS. We are also very prolific in using AI for our advantage but that could not replace the intuitiveness of the Entries model.”
Alaa Salonen Monidose CEO_square
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MoniDose
Entries was game changing… it gave us clarity, confidence, and a foundation we couldn’t replace with any other tool—or even with AI.
Alaa Salonen
CEO and Founder of MoniDose

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