エマーゴは、ヘルスケア業界の規制や遵守に関する問題を解決します。

Doctor listening to baby's heart

製品ライフサイクルのすべての段階において、総合的なサービスを提供致します。

RAMS®

薬事法規制対応のオールインワンソリューション

OPUS™

Optimal Product Usability Suite (OPUS™ ) ― Emergo by ULの最新ヒューマンファクタツールでは、トレーニング、ツール、資料を利用いただけます。

当社のソフトウェアツールは、医療機器コンプライアンスのためのデジタル規制モニタリングおよび人間工学ツールを提供します。

最新の規制及び業界関連ニュース。

ニュースレター

RADAR : Market Access Newsletter

最もよく読まれているRA/QA医療機器ニュースレターで、常に情報を入手できます。

TalkingPoints : Human Factors Newsletter

TalkingPointsは、医療機器、体外診断用医療機器、コンビネーション製品をはじめ、さまざまな製品において大切な要素となるヒューマンファクタ/ユーザビリティに関する情報をお届けするニュースレターです。

弊社は、6大陸20箇所以上の拠点にてグローバルコンサルティングを提供し、

Team collaborating on post-its

チームメンバー

当社のコンサルタントは、医療機器規制関連業務、ヒューマンファクタ、臨床研究、サイバーセキュリティの分野で数十年にわたる経験を有しています。

お問合せ

Alison Strochlic

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

Andrea Dwyer

Andrea Dwyer: Associate Research Director, HFR&D; Andrea Dwyer has been with Emergo by UL’s Human Factors Research & Design (HFR&D) team since 2010.

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 user interfaces, from concept to production.

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 experience delivering human factors engineering (HFE) services to the medical device and pharmaceutical industries.

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 many other facets of product development.

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 engineering needs, particularly for complex and high-risk systems.

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 Human Factors Research & Design team and is available to help customers address their most important human factors challenges.

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 pain points.

Alexandria Carlson

Alexandria Carlson: Lead Human Factors Specialist; Alexandria Carlson has expertise in conducting formative and HF validation usability tests and developing key documents for customers’ design history files, including user profiles, use environment descriptions, and known problems analysis.

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 has been with the team since 2013.

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 affairs background with her.

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 implants and active devices

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 quality management systems.

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 devices worldwide.

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 approvals in Europe.

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 devices, and covering products of all risk classifications.

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 implantable devices, electrical medical equipment and disposables subject to INMETRO Certification.

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 classes, including implantable devices, ophthalmic products and medication delivery products.

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. Regulatory Submissions.

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 Engineering Manager.

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, primarily focused on orthopedic devices, including implantable devices.

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 global regulatory experience.

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 and In Vitro Diagnostics (IVDs).

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 Emergo by UL in Brazil.

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 high-risk device regulatory submissions and quality assurance requirements.

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 and providing input on business decisions and strategy.

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 radiology devices, including stents.

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 international regulatory compliance, focused primarily on the US and EU. Her areas of specialization include MDR/IVDR transition, and Qua

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 successful MDR and IVDR transitions.

Sade Sobande

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

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 devices, including immunohematology and blood virus.

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 devices, and covering products of all risk classifications.

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 strategy and compliance oversight for market approvals.

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 classes, including implantable devices, ophthalmic products and medication delivery products.

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 global regulatory experience.

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 and providing input on business decisions and strategy.

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 successful MDR and IVDR transitions.

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