Shaping regulatory and clinical strategy from the start
A medical device company needed clarity on how to align their clinical development and regulatory pathway early in product development. Aurevia facilitated a tailored workshop, bringing together key stakeholders to define a clear roadmap based on intended use, target markets, and business goals. The workshop delivered actionable guidance on clinical evidence and regulatory requirements, and key risk areas, followed by a structured report to support next steps—helping the client move forward with greater confidence and a more efficient path to market.
How Forsante uses AI & automation for better quality of care
Forsante Oy’s MDR-certified IRMA decision engine helps automate clinical processes, reduce manual work, and supports more consistent treatment pathways.
We’re proud to have supported Forsante in building its ISO 13485 quality management system and technical documentation aligned with MDR requirements. This is a great example that highlights the value of combining innovation with the right regulatory expertise.
As Antti Särelä, CEO of Forsante puts it, "Aurevia's experts understood the needs of a small company well and were able to tailor solutions that suit us without extra burden. Our collaboration with Aurevia covered everything from building a quality system to compiling a technical file. Our goal was to get an optimally built system that is not too heavy but meets all the requirements."
How MoniDose strengthened their regulatory confidence—fast
When MoniDose began their startup journey, regulations were their biggest challenge. Missing early design inputs tied to standards could have meant costly redesigns later.
Utilizing Lean Entries e-tools changed that by:
✔ Ensuring all critical regulatory design inputs were captured early
✔ Raising the team’s confidence in their compliance strategy
✔ Helping convince investors they had regulatory clarity and a focused regulatory strategy
If you're a startup in need of regulatory guidance, we can provide you with the structure, clarity, and confidence to move forward quickly and strategically.
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Our customer-centric approach means that our client’s needs guide our focus to create impactful results.
We prioritize transparency, dependability, and delivering high-quality results.
We deliver agile, tailored solutions through deep expertise and a commitment to excellence.
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