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A platform of digital products to improve, simplify and automate RA/QA activities

OPUS™

Emergo by UL's new human factors tool - provides training, tools, and resources.

Our software tools offer digital regulatory monitoring for medical device compliance and access to human factors engineering tools.

The latest industry news and insights from our global team.

RADAR : Market Access Newsletter

Stay informed with the most read RA/QA medical device newsletter.

TalkingPoints : Human Factors Newsletter

TalkingPoints is a round-up of news, insights, and resources about human factors and usability for medical devices, IVDs, combination products, and more.

Learn from our experts through live events.

Our global consulting team works from 20+ offices on six continents.

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Our Consultants

Our consultants can draw on decades of experience in medical device regulatory affairs, human factors engineering, clinical research, and cybersecurity to help you.

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Alison Strochlic

Allison Strochlic: Senior Research Director; Allison was one of the Emergo by UL, Human Factors Research & Design team’s co-founders in 2005.

Andrea Dwyer

Andrea Sutton: Research Director, HFR&D; A board-certified human factors professional, Andrea Sutton leads and oversees research activities required to meet...

Cory Costantino

Cory Costantino: Design Director, HFR&D; For over 20 years, Cory has helped guide products, from hand-held consumer electronics to medical devices and software...

Erin Davis

Erin Davis: Associate Research Director, HFR&D; Erin Davis has been with Emergo by UL’s Human Factors Research & Design (HFR&D) team since 2012.

Flemming Flindt

Flemming Flindt: Sales Director, HFR&D; Flemming has more than 20 years of experience leading commercial activities in the MedTech and Pharmaceutical industry.

Laura Birmingham

Laura Birmingham: Associate Research Director, HFR&D; Laura Birmingham has been with Emergo by UL’s Human Factors Research & Design team since 2011 and has extensive...

Mark Tavano

Mark Tavano: Sales Director, HFR&D; Mark has over 25 years of industry experience. He has deep knowledge of human factors and industrial design, as well as...

Merrick Kossack

Merrick Kossack: Research Director, HFR&D; For over 25 years, Merrick has helped companies develop processes and strategies to address their human factors...

Michael Wiklund

Michael Wiklund: Leader, Life Science Industry Practice; Michael leads the Life Science Industry Practice of UL Solutions. He also serves as a senior advisor to Emergo by UL’s...

Tess Forton

Tess Forton: Managing User Researcher; Tess has expertise in conducting discovery research at the start of product development to understand key user needs and...

Alexandria Carlson

Alexandria Carlson: Lead Human Factors Specialist; Alexandria Carlson has expertise in conducting formative and HF validation usability tests and developing key documents...

Frauke Schuurkamp

Frauke Schuurkamp: Managing Human Factors Specialist; Frauke Schuurkamp is a managing human factors specialist with Emergo by UL’s Human Factors Research & Design team. She...

Annette Van Raamsdonk

Annette Van Raamsdonk - Netherlands: Lead Quality and Regulatory Affairs; Annette van Raamsdonk, LL.M., joined the Emergo team in The Netherlands in 2017, bringing an extensive regulatory...

Dasun Abey

Dasun Abey - France: Lead Quality and Regulatory Affairs; Dasun Abey has solid industry experience in regulatory affairs with a focus on high-risk devices, including orthopedic...

Heather Crawford

Heather Crawford - United States: Lead Quality and Regulatory Affairs; Heather Crawford has over 20 years of experience in the medical device industry, specializing in regulatory affairs and...

Linda Chatwin

Linda Chatwin - United States: Lead Quality and Regulatory Affairs; Ms. Chatwin has obtained approvals for a wide range of products, remains involved in changing requirements for medical...

Lori White

Lori White - United States: Senior Quality and Regulatory Affairs Consultant; Lori White has over 10 years of medical device industry experience, primarily in global regulatory strategy and product...

Sreenu Sattu

Sreenu Sattu - India: Manager Quality Assurance and Regulatory Affairs; Sreenu Sattu has over 17 years of healthcare industry experience, focusing on medical devices and in vitro diagnostic...

Luiz Levy

Luiz Levy - Brazil: Manager, Quality and Regulatory Affairs Brazil; Luiz Levy has over ten years of medical device industry experience, primarily focused on high-risk devices, including...

Luana Zerafa

Luana Zerafa - United Kingdom: Senior Consultant, Quality and Regulatory Affairs; Luana Zerafa has over 10 years of industry experience, working with medical devices and applicable regulations in all...

Giselle Zhang

Giselle Zhang - China: Consultant, Quality and Regulatory Affairs; Giselle Zhang has five years of combined RA/QA experience in the medical device industry, primarily focused on U.S....

Thomas Huang

Thomas Huang - Taiwan: Consultant, Quality and Regulatory Affairs; Thomas Huang joined the Emergo by UL consulting team in 2020, following several years as a UL Lead Auditor and...

Elizabeth Pugh

Elizabeth Pugh - United States: Senior Consultant, Regulatory Affairs; Elizabeth Pugh has been a consultant with Emergo by UL since 2011 and has over 14 years of industry experience,...

Evangeline Loh

Evangeline Loh - United States: Global Manager, Regulatory Affairs; Evangeline Loh holds one of the most senior positions in the Emergo by UL consulting group and has over 15 years of...

Karen Hill

Karen Hill - United Kingdom: Senior Consultant, Regulatory Affairs; Karen Hill has over 20 years of Medical Device industry experience, primarily focused on high-risk, implantable devices...

Priscila Sanada

Priscila Sanada - Brazil: RA/QA Regulatory Affairs Manager (Latin America); Priscila Sanada has over 13 years of Regulatory Affairs experience and is a valuable member of the consulting team of...

Rachel Paul

Rachel Paul - France: Senior Consultant, Quality and Regulatory Affairs; Rachel Paul has over 13 years of experience in the medical device industry as well as international experience in...

Ken Pilgrim

Ken Pilgrim - Canada: Manager, Regulatory Affairs; Ken Pilgrim has over 20 years of industry experience at the Manager/Director level, overseeing corporate quality systems...

Roxana Cernescu

Roxana Cernescu - Germany: Senior Consultant, Quality and Regulatory Affairs; Roxana Cernescu has more than 25 years of medical device industry experience, primarily in interventional cardiology and...

Sharon Chen

Sharon Chen - Taiwan: Lead Quality & Regulatory Affairs Consultant; Sharon Chen is located in Taiwan and is an experienced consultant who supports medical device manufacturers with...

Tom Ingless

Tom Ingless - United Kingdom: Senior Consultant, Quality and Regulatory Affairs; Tom Ingless has over 7 years of experience in regulatory affairs throughout the healthcare industry, with a focus on...

Sade Sobande

Sade Sobande: Lead QA/RA consultant; Sade Sobande is an RAC-Devices accredited regulatory affairs professional who specializes in regulatory strategy and...

Lilian Pinheiro

Lilian Pinheiro - Brazil: Consultant, Regulatory Affairs (Latin America); Lilian Pinheiro is located in Brazil and has over 10 years of industry experience, primarily focused on high-risk IVD...

Sreenu Sattu

Sreenu Sattu - India: Manager Quality Assurance and Regulatory Affairs; Sreenu Sattu has over 17 years of healthcare industry experience, focusing on medical devices and in vitro diagnostic...

Dayeon Choi

DaYeon Choi - South Korea: Quality and Regulatory Affairs Consultant; DaYeon Choi has over 3 years of regulatory experience with in-vitro diagnostic medical devices and provided regulatory...

Luana Zerafa

Luana Zerafa - United Kingdom: Senior Consultant, Quality and Regulatory Affairs; Luana Zerafa has over 10 years of industry experience, working with medical devices and applicable regulations in all...

Evangeline Loh

Evangeline Loh - United States: Global Manager, Regulatory Affairs; Evangeline Loh holds one of the most senior positions in the Emergo by UL consulting group and has over 15 years of...

Ken Pilgrim

Ken Pilgrim - Canada: Manager, Regulatory Affairs; Ken Pilgrim has over 20 years of industry experience at the Manager/Director level, overseeing corporate quality systems...

Tom Ingless

Tom Ingless - United Kingdom: Senior Consultant, Quality and Regulatory Affairs; Tom Ingless has over 7 years of experience in regulatory affairs throughout the healthcare industry, with a focus on...

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