# Emergo by UL

> Emergo by UL provides regulatory consulting, human factors research and design, in-country representation and compliance software for medical device and IVD manufacturers. Part of UL Solutions, it combines international market-access expertise with RAMS regulatory software and OPUS human factors tools.

- **Founded:** 1997
- **Headquarters:** Austin, United States
- **Founders:** René van de Zande (Founder; former president and CEO)
- **Products:** RAMS - Regulatory Affairs Management Suite, OPUS - Optimal Product Usability Suite, Global market access and device registration, Human Factors Research & Design, In-country representation
- **Notable:** Founded in 1997 and acquired by UL in 2017., RAMS launched in 2019; OPUS introduced in 2022., Supported Nuubo human factors and electrode-performance work during 2016-2018; the Nuubo System received FDA 510(k) clearance in August 2018.

## Products & services

- **RAMS - Regulatory Affairs Management Suite** — SaaS for product classification, guided regulatory documentation, regulatory reports and intelligence, regulatory monitoring and registration tracking.
- **OPUS - Optimal Product Usability Suite** — Cloud-based human factors engineering platform with training, tools, templates, document libraries and regulatory guidance.
- **Global market access and device registration** — Regulatory strategy, classification, submission preparation and device registration support for medical devices and IVDs.
- **Human Factors Research & Design** — User research, interface design, formative studies, human factors validation and use-related risk analysis.
- **In-country representation** — Independent local regulatory representation and registration management across international markets.
- **Quality and regulatory consulting** — ISO 13485 QMS implementation and audits, compliance assessments and regulatory affairs support.
- **Post-market surveillance** — Post-market surveillance, vigilance, incident reporting and related compliance support.

## Achievements

- Founded in 1997 and acquired by UL in 2017.
- RAMS launched in 2019; OPUS introduced in 2022.
- Supported Nuubo human factors and electrode-performance work during 2016-2018; the Nuubo System received FDA 510(k) clearance in August 2018.
- Smith+Nephew case study documents interface design, formative testing and human factors validation for myTSF.
- ISO 13485 certification covers specified Medical Market Access services and offices, excluding Human Factors Research & Design.

## Latest updates

- **2026-09** — Published a September 1 guide to formative product evaluations by Emilee Stanczyk and Johanna Thommai.
- **2026-09** — Published EAAR 2026 coverage of EU regulatory developments on September 13.
- **2026-10** — Published Bringing a Medical Device to the US Market: Perspectives and Considerations on October 1.

## Links

- Website: https://www.emergobyul.com
- LinkedIn: https://www.linkedin.com/company/emergobyul/
- Twitter/X: https://twitter.com/EmergoGroup
- YouTube: https://www.youtube.com/user/TheEmergoGroup
- Facebook: https://www.facebook.com/emergobyul/

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Profile page: https://yespress.io/emergo-by-ul
Published by YesPress — https://yespress.io
Last updated: 2026-10-02