FAQ

Unitron Medx is a medical technology company specializing in regulatory support and manufacturing of medical devices. With offices in the United States, Belgium, and the Netherlands, we support global partners in developing safe, certified, and high-quality medical products.

At Unitron Medx, we guide our partners through the entire lifecycle of medical device development: from concept and design to regulatory approval and full-scale manufacturing.

• In-house engineering and regulatory teams

• Advanced prototyping and iterative testing

• Deep knowledge of ISO 13485, FDA, and global standards

We combine technical excellence with up-to-date regulatory expertise to accelerate innovation without compromising quality.

Our quality systems comply with:

• ISO 13485 (medical device quality standard)

• FDA (U.S.) and Ordinance 169 (Japan)

• IPC-A-610D Class 2 for production quality

This allows us to manufacture for the European, American, and Japanese markets. With decades of experience, we ensure full compliance with the strictest international medical regulations.

Unitron Medx is your trusted partner for medical technology innovation, offering:

• Full-service support from idea to market

• Flexible, scalable solutions tailored to your needs

• Collaborative development with deep industry insight

Whether you're a startup or a global company, our experts help you bring impactful, compliant products to market: faster and smarter.

We ensure compliance through:

• Certified quality systems (ISO 13485, FDA, etc.)

• Experienced in-house regulatory experts

• Robust documentation and process control

From CE marking to FDA 510(k), we guide you through every step of the compliance journey.

We add value for:

• Startups needing guidance with design and regulatory hurdles

• Scale-ups and medtech companies aiming to accelerate development

• Hospitals and research institutes co-developing custom equipment

• Manufacturers seeking a certified, reliable production partner

Whether you're launching a new idea or optimizing an existing device, Unitron Medx helps turn your concept into a certified, market-ready medical product:  efficiently and reliably.

Get in contact with us via: Contact - Unitron Medx or follow us on LinkedIn: @UnitronMedx