Innovation

Regulation

Translation

We help healthcare innovators transform ideas into successful products.

AMIQALY supports healthcare innovators in navigating the journey from research and development to regulatory approval, market access, and real-world impact.

We combine strategic innovation support with practical regulatory expertise, helping organizations bring novel healthcare products and services to patients faster, more efficiently, and with greater confidence.

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Practices

Innovation Translation

Regulatory Services

MDR & IVDR consulting ✦ Regulatory strategy ✦ Digital health & SaMD ✦ AI-enabled products ✦ Clinical & performance evaluation ✦ Evidence generation ✦ QMS support ✦ Market access ✦

01 — Our expertise

Two practices, one continuous journey.

Many innovations fail not because the science is weak, but because regulatory, evidence and commercialization requirements are considered too late.

01

Innovation Translation

Turning promising ideas into viable healthcare products.

AMIQALY helps innovators understand these requirements early — and build them into the development path rather than around it.

Innovation-to-market strategy

Regulatory feasibility assessment

Product qualification and classification

Evidence generation planning

Commercialization support

Regulatory support for research and innovation projects

Regulatory due diligence for investors and accelerators

02

Regulatory Services

Expert guidance across the product lifecycle.

Practical regulatory support for medical technologies, diagnostics, digital health, AI-enabled healthcare products, ATMPs and pharmaceutical products.

MDR and IVDR consulting

Medical device and IVD classification

Regulatory strategy and planning

Technical documentation review

Clinical and performance evaluation support

Digital health and SaMD regulatory strategy

AI and healthcare regulatory considerations

Quality management system support

Regulatory gap assessments

Regulatory readiness reviews

Post-market regulatory support

02 — What we answer

We help innovators understand

Most regulatory consultancies focus primarily on compliance. AMIQALY combines regulatory expertise with a deep understanding of healthcare innovation — answering the critical questions long before submission.

001

What product they are developing

002

Which regulatory framework may apply

003

What evidence will be required

004

How development activities should be prioritized

005

How to prepare for future compliance and market access

Our goal

To help innovators make better decisions earlier and accelerate the translation of innovation into successful products.

03 — The team

Four people, one bench of expertise.

Rudolf Fryček

Innovation & product

Expert in healthcare technologies, innovation management, and product development.

Martina Nešverová

Strategy & EU projects

Expert in healthcare innovation, regulatory strategy, commercialization planning, and European research and innovation projects.

Mirko Micucci

Regulatory expert

MDR/IVDR regulatory strategy, QMS, design assurance, and compliance for devices, IVDs and AI-enabled healthcare products.

Hana Potočková

Regulatory expert

Full bio coming soon.

04 — Contact

Let's talk about your product.

Reach out and we'll help you understand what's next for your innovation.

Start a conversation

Website

www.amiqaly.com

info@amiqaly.com

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Location

Prague