Denise Forkey
Director, Human Factors Strategy - Advisory at ClariMed, Inc. | San Jose, California, United States
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Denise Forkey serves as the Director of Human Factors Strategy - Advisory at ClariMed, Inc., where she leverages her extensive background in human factors and biomedical engineering to guide medical device and combination product companies through the complexities of usability engineering and regulatory compliance. With a robust foundation in medical device development, Denise is adept at navigating the intricacies of usability testing and human factors research, ensuring that products not only meet regulatory standards but also resonate with end-users, including healthcare professionals and patients.
In her current role, Denise is instrumental in advising clients on the strategic implementation of human factors engineering programs. She provides expert insights into project strategies for novel medical products, emphasizing the importance of user-centered design and compliance documentation to enhance product safety and efficacy. Her cross-functional leadership experience allows her to collaborate effectively with diverse teams, including marketing, operations, and quality assurance, to streamline processes and ensure successful product launches.
Denise’s wide-ranging expertise encompasses usability engineering, regulatory affairs, and commercialization, making her a valuable asset in the medical device industry. She is particularly skilled in developing training strategies that empower teams to understand and implement best practices in human factors engineering. By staying abreast of FDA guidelines and industry trends, Denise ensures that her clients are well-prepared to navigate the regulatory landscape, ultimately leading to successful market entry and improved patient outcomes. Her commitment to excellence and innovation positions her as a thought leader in the field, driving advancements in medical device usability and user experience.
Director, Human Factors Strategy - Advisory at ClariMed, Inc. in September 2023 to Present
Director, Human Factors at ClariMed, Inc. in January 2023 to September 2023
Director Human Factors (Manager Human Factors<Sr. Human Factors Engineer<HF Specialist Contractor) at UserWise, Inc. in May 2016 to January 2023
Biomedical Consultant at Denise Forkey Medical Device Development Solutions in January 2016 to April 2020
Board Member at Biomedical Engineering Society in October 2017 to October 2018
Sr. Director of Marketing and Corporate Communications at Surpass, Inc in October 2014 to January 2016
Sr Director of Marketing and Client Services at Surpass, Inc in March 2013 to October 2014
Sr Director of Business Development and Regulatory Affairs at Surpass-Silicon Valley (formerly LyChron, LLC) in January 2013 to March 2013
Sr. Director of Business Development and Regulatory Affairs Positions at Surpass-Silicon Valley (formerly LyChron, LLC) in December 2007 to January 2013
Director of Operations and Regulatory Compliance at Surpass-Silicon Valley (formerly LyChron, LLC) in May 2003 to December 2007
Director of Operations and Quality Assurance at Surpass-Silicon Valley (formerly LyChron, LLC) in January 2002 to May 2003
Preclinical Engineer thru Project Group Lead Preclinical Research at Guidant in January 1998 to January 2002
Biomedical Engineering Assistant at Maven Laboratories (name changed to Woodside Biomedical) in September 1996 to November 1997
Biomedical Engineering Consultant at Ergomed in August 1997 to October 1997
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Training Plans
Presentations
Interpersonal Relationships
Training Strategy
Human Factors Validation
Usability Engineering
Formative Evaluation
Use-related risk analysis
Usability Testing
Human Factors Engineering
Medical Devices
FDA
Clinical Development
Regulatory Affairs
Biotechnology
Cross-functional Team Leadership
Biomedical Engineering
R&D
ISO 13485
GLP
Life Sciences
Commercialization
Validation
Clinical Research
Lifesciences
Quality System
Product Development
Clinical Trials
Product Launch
Medical Imaging
Quality Assurance
CAPA
Project Management
Sop
Protocol
Laboratory
Pharmaceutical Industry
Vascular
Interventional Cardiology
Drug Development
CRO
Marketing Communications
SEO Copywriting
Social Media Marketing
U.S. Food and Drug Administration (FDA)
Good Laboratory Practice (GLP)
Standard Operating Procedure (SOP)
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What is Denise Forkey email address?
Email Denise Forkey at [email protected] and [email protected]. This email is the most updated Denise Forkey email found in 2026.
What is Denise Forkey phone number?
Denise Forkey phone number is +19164784275 and +16509382101.
How to contact Denise Forkey?
To contact Denise Forkey send an email to [email protected] or [email protected]. If you want to call Denise Forkey try calling on +19164784275 and +16509382101. (updated on October 31, 2024)
What company does Denise Forkey work for?
Denise Forkey works for ClariMed, Inc.
What is Denise Forkey's role at ClariMed, Inc.?
Denise Forkey is Director, Human Factors Strategy - Advisory
What industry does Denise Forkey work in?
Denise Forkey works in the Medical Equipment Manufacturing industry.
Denise Forkey Email Addresses
Denise Forkey Phone Numbers
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