QARAlink debuts AI-powered regulatory intelligence platform at Medica 2025

Swiss start-up unveils its platform and opens Early Access Program to help shape the future of regulatory compliance in MedTech.

Düsseldorf, Germany – 17 November 2025 — QARAlink , a Swiss start-up transforming how MedTech and HealthTech companies manage regulatory compliance, officially unveiled its AI-powered platform at Medica 2025 , the world’s largest medical trade fair (Hall 12 – Stand 12D19/1, Swiss Start-up Corner).

QARAlink’s mission is to make global compliance easier, smarter, and faster – helping manufacturers and regulatory teams cut through complexity, adapt to constant change, and reach new markets with confidence. By structuring the world’s regulatory frameworks, from MDR and IVDR to FDA and AI regulations, into a unified knowledge system, QARAlink enables teams to turn uncertainty into clarity, and compliance work into actionable progress.

“MedTech companies lose a lot of time trying to keep up with changing requirements,” says Tom Petty, PhD, Co-Founder and CEO of QARAlink. “We built QARAlink to remove friction, combining trusted human expertise with AI assistance, so teams can focus on getting products approved and keeping them compliant, without the guesswork. We help teams get smarter, build stronger regulatory strategies, and move faster than ever before.”

The event marks the official launch of QARAlink’s AI-powered regulatory intelligence platform, built to help MedTech and HealthTech teams simplify global compliance.

The platform offers a secure, centralized environment where users can:

Identify applicable regulatory pathways in minutes,
Track global rule changes in real time, and
Generate tailored compliance plans for each product and market.

Built on trusted cloud infrastructures, QARAlink ensures enterprise-grade security, scalability, and data protection, making it suitable for organizations of any size.

As part of its launch, QARAlink is opening an Early Access Program, inviting MedTech companies to join and contribute to shaping the platform’s evolution. Early adopters will gain access to new features designed to further simplify global compliance management.

Tom Petty will speak on Thursday, November 20, in the session “GLOBAL MARKET ACCESS – Scaling MedTech innovations with validated products and certified processes.” His presentation will show how structured regulatory intelligence can reduce the time, effort, and cost of achieving and maintaining market certifications worldwide.

Visit QARAlink at Medica 2025 (Swiss Start-up Corner, Hall 12 – Stand 12D19-8) and accelerate your compliance journey to maximize your impact on the people who need your technology the most.

About QARAlink

QARAlink SA is a Swiss regulatory intelligence startup helping MedTech and HealthTech companies plan, execute and govern compliance with confidence. With a mission to simplify and modernize compliance and better connect Quality Assurance (QA) and Regulatory Affairs (RA) teams, QARAlink helps companies thrive in a complex global regulatory environment. Founded in 2024, the company is headquartered in Denges, Switzerland.

Global compliance. Smarter, Stronger, Faster.

For more information, visit QARAlink.com, or connect on LinkedIn.

Media Contact:

Sophie Reymond

sophie@srpr.ch

Exhibitor Data Sheet