Denise has over 25 years of experience in medical device and combination product testing with experience in human factors engineering, pre-clinical testing, R&D and quality engineering. The last 5 years Denise has directed her efforts to Human Factors and Usability Engineering of complex medical devices, combination products, and consumer based medical products. She joined UserWise in early 2016 and leads human factors engineering projects for injectables through robotic surgery systems. She partners with UserWise clients on human factors strategy for FDA and international human factors submissions as well as any and all aspects of the usability engineering process. Denise has experience developing use-related risk analyses; preparing documentation for and executing formative and summative usability evaluations and human factors validation testing; authoring Human Factors Engineering Submission Reports for FDA; and providing human factors engineering training sessions. She also assists UserWise clients with gap analyses and compliance documentation for IEC 62366:2007, IEC 62366-1:2015, IEC 60601-1-6, and FDA Human Factors Guidance Documents.

Miles first joined UserWise as an intern for the summer of 2018 and came on as a full-time consultant in mid-2019. He is experienced in forming use-related risk analyses and test protocols; observing usability study sessions for formative and validation testing; preparing test reports, risk-benefit analyses and Human Factors Engineering Submission Reports for FDA; providing human factors trainings and workshops; and with establishing compliance documentation for IEC 62366:2007, IEC 62366-1:2015, and FDA Guidance Documents. His focus is predominantly on combination products. Miles brings a wide range of pertinent experience from his undergraduate career, including serving as a research assistant, developing a stress-sensing wearable device and accompanying application, and participation in design studios.

Denise has over 25 years of experience in medical device and combination product testing with experience in human factors engineering, pre-clinical testing, R&D and quality engineering. The last 5 years Denise has directed her efforts to Human Factors and Usability Engineering of complex medical devices, combination products, and consumer based medical products. She joined UserWise in early 2016 and leads human factors engineering projects for injectables through robotic surgery systems. She partners with UserWise clients on human factors strategy for FDA and international human factors submissions as well as any and all aspects of the usability engineering process. Denise has experience developing use-related risk analyses; preparing documentation for and executing formative and summative usability evaluations and human factors validation testing; authoring Human Factors Engineering Submission Reports for FDA; and providing human factors engineering training sessions. She also assists UserWise clients with gap analyses and compliance documentation for IEC 62366:2007, IEC 62366-1:2015, IEC 60601-1-6, and FDA Human Factors Guidance Documents.

Miles first joined UserWise as an intern for the summer of 2018 and came on as a full-time consultant in mid-2019. He is experienced in forming use-related risk analyses and test protocols; observing usability study sessions for formative and validation testing; preparing test reports, risk-benefit analyses and Human Factors Engineering Submission Reports for FDA; providing human factors trainings and workshops; and with establishing compliance documentation for IEC 62366:2007, IEC 62366-1:2015, and FDA Guidance Documents. His focus is predominantly on combination products. Miles brings a wide range of pertinent experience from his undergraduate career, including serving as a research assistant, developing a stress-sensing wearable device and accompanying application, and participation in design studios.

Denise has over 25 years of experience in medical device and combination product testing with experience in human factors engineering, pre-clinical testing, R&D and quality engineering. The last 5 years Denise has directed her efforts to Human Factors and Usability Engineering of complex medical devices, combination products, and consumer based medical products. She joined UserWise in early 2016 and leads human factors engineering projects for injectables through robotic surgery systems. She partners with UserWise clients on human factors strategy for FDA and international human factors submissions as well as any and all aspects of the usability engineering process. Denise has experience developing use-related risk analyses; preparing documentation for and executing formative and summative usability evaluations and human factors validation testing; authoring Human Factors Engineering Submission Reports for FDA; and providing human factors engineering training sessions. She also assists UserWise clients with gap analyses and compliance documentation for IEC 62366:2007, IEC 62366-1:2015, IEC 60601-1-6, and FDA Human Factors Guidance Documents.

Miles first joined UserWise as an intern for the summer of 2018 and came on as a full-time consultant in mid-2019. He is experienced in forming use-related risk analyses and test protocols; observing usability study sessions for formative and validation testing; preparing test reports, risk-benefit analyses and Human Factors Engineering Submission Reports for FDA; providing human factors trainings and workshops; and with establishing compliance documentation for IEC 62366:2007, IEC 62366-1:2015, and FDA Guidance Documents. His focus is predominantly on combination products. Miles brings a wide range of pertinent experience from his undergraduate career, including serving as a research assistant, developing a stress-sensing wearable device and accompanying application, and participation in design studios.

Denise has over 25 years of experience in medical device and combination product testing with experience in human factors engineering, pre-clinical testing, R&D and quality engineering. The last 5 years Denise has directed her efforts to Human Factors and Usability Engineering of complex medical devices, combination products, and consumer based medical products. She joined UserWise in early 2016 and leads human factors engineering projects for injectables through robotic surgery systems. She partners with UserWise clients on human factors strategy for FDA and international human factors submissions as well as any and all aspects of the usability engineering process. Denise has experience developing use-related risk analyses; preparing documentation for and executing formative and summative usability evaluations and human factors validation testing; authoring Human Factors Engineering Submission Reports for FDA; and providing human factors engineering training sessions. She also assists UserWise clients with gap analyses and compliance documentation for IEC 62366:2007, IEC 62366-1:2015, IEC 60601-1-6, and FDA Human Factors Guidance Documents.

Miles first joined UserWise as an intern for the summer of 2018 and came on as a full-time consultant in mid-2019. He is experienced in forming use-related risk analyses and test protocols; observing usability study sessions for formative and validation testing; preparing test reports, risk-benefit analyses and Human Factors Engineering Submission Reports for FDA; providing human factors trainings and workshops; and with establishing compliance documentation for IEC 62366:2007, IEC 62366-1:2015, and FDA Guidance Documents. His focus is predominantly on combination products. Miles brings a wide range of pertinent experience from his undergraduate career, including serving as a research assistant, developing a stress-sensing wearable device and accompanying application, and participation in design studios.

Denise has over 25 years of experience in medical device and combination product testing with experience in human factors engineering, pre-clinical testing, R&D and quality engineering. The last 5 years Denise has directed her efforts to Human Factors and Usability Engineering of complex medical devices, combination products, and consumer based medical products. She joined UserWise in early 2016 and leads human factors engineering projects for injectables through robotic surgery systems. She partners with UserWise clients on human factors strategy for FDA and international human factors submissions as well as any and all aspects of the usability engineering process. Denise has experience developing use-related risk analyses; preparing documentation for and executing formative and summative usability evaluations and human factors validation testing; authoring Human Factors Engineering Submission Reports for FDA; and providing human factors engineering training sessions. She also assists UserWise clients with gap analyses and compliance documentation for IEC 62366:2007, IEC 62366-1:2015, IEC 60601-1-6, and FDA Human Factors Guidance Documents.

Miles first joined UserWise as an intern for the summer of 2018 and came on as a full-time consultant in mid-2019. He is experienced in forming use-related risk analyses and test protocols; observing usability study sessions for formative and validation testing; preparing test reports, risk-benefit analyses and Human Factors Engineering Submission Reports for FDA; providing human factors trainings and workshops; and with establishing compliance documentation for IEC 62366:2007, IEC 62366-1:2015, and FDA Guidance Documents. His focus is predominantly on combination products. Miles brings a wide range of pertinent experience from his undergraduate career, including serving as a research assistant, developing a stress-sensing wearable device and accompanying application, and participation in design studios.

Denise has over 25 years of experience in medical device and combination product testing with experience in human factors engineering, pre-clinical testing, R&D and quality engineering. The last 5 years Denise has directed her efforts to Human Factors and Usability Engineering of complex medical devices, combination products, and consumer based medical products. She joined UserWise in early 2016 and leads human factors engineering projects for injectables through robotic surgery systems. She partners with UserWise clients on human factors strategy for FDA and international human factors submissions as well as any and all aspects of the usability engineering process. Denise has experience developing use-related risk analyses; preparing documentation for and executing formative and summative usability evaluations and human factors validation testing; authoring Human Factors Engineering Submission Reports for FDA; and providing human factors engineering training sessions. She also assists UserWise clients with gap analyses and compliance documentation for IEC 62366:2007, IEC 62366-1:2015, IEC 60601-1-6, and FDA Human Factors Guidance Documents.

Miles first joined UserWise as an intern for the summer of 2018 and came on as a full-time consultant in mid-2019. He is experienced in forming use-related risk analyses and test protocols; observing usability study sessions for formative and validation testing; preparing test reports, risk-benefit analyses and Human Factors Engineering Submission Reports for FDA; providing human factors trainings and workshops; and with establishing compliance documentation for IEC 62366:2007, IEC 62366-1:2015, and FDA Guidance Documents. His focus is predominantly on combination products. Miles brings a wide range of pertinent experience from his undergraduate career, including serving as a research assistant, developing a stress-sensing wearable device and accompanying application, and participation in design studios.