Combo Products

Human Factors Regulatory And Strategy (HURAS)


Kymanox HURAS provides turnkey comprehensive human factors (HF) solutions and strategies from product conception through post-market and lifecycle management.


Contact Us

Human Factors Regulatory And Strategy (HURAS)


Kymanox HURAS provides turnkey comprehensive human factors (HF) solutions and strategies from product conception through post-market and lifecycle management.


Contact Us


Our Experience

We provide customized Human Factors (HURAS) Regulatory and Strategy for Your Programs to Ensure:

  • A Right first-time Submission
  • Clear Regulatory Communication and Documentation
  • Thorough Integration into Design Controls and your Quality System
  • Post-Market Signal Detection and Lifecycle Management

Kymanox can provide guidance and support to conform to current industry practices, standards, and to comply to FDA regulations:

  • Design Controls and Design History Files
  • ISO 14971, Medical Devices – Application of Risk Management to Medical Devices
  • IEC 62366 Medical Devices – Application of Usability Engineering to Medical Devices
  • Medical Device Directive (MDD) 93/42/EEC
  • Medical Device Regulations (MDR)
  • 21 CFR 820, Quality System Regulation
  • CFR Part 4, Combination Products
For more information on our Services and Capabilities, please review our HURAS Capabilities Document.


Our Experience

We provide customized Human Factors (HURAS) Regulatory and Strategy for Your Programs to Ensure:

  • A Right first-time Submission
  • Clear Regulatory Communication and Documentation
  • Thorough Integration into Design Controls and your Quality System
  • Post-Market Signal Detection and Lifecycle Management

Kymanox can provide guidance and support to conform to current industry practices, standards, and to comply to FDA regulations:

  • Design Controls and Design History Files
  • ISO 14971, Medical Devices – Application of Risk Management to Medical Devices
  • IEC 62366 Medical Devices – Application of Usability Engineering to Medical Devices
  • Medical Device Directive (MDD) 93/42/EEC
  • Medical Device Regulations (MDR)
  • 21 CFR 820, Quality System Regulation
  • CFR Part 4, Combination Products
For more information on our Services and Capabilities, please review our HURAS Capabilities Document.


Insights


Infographic: Human Factors - Enjoy the Journey and the Destination!


Human Factors (HF) is not just a validation exercise or a check box at the end of your product development process. HF can help answer the question of whether you have designed the right product for your users by exploring new paths so enjoy the journey!

Bookmark(0)


Insights


Infographic: Human Factors - Enjoy the Journey and the Destination!


Human Factors (HF) is not just a validation exercise or a check box at the end of your product development process. HF can help answer the question of whether you have designed the right product for your users by exploring new paths so enjoy the journey!


Bookmark(0)

Human Factors Planning 101


Learn more about the Human Factors Plan including a handy checklist of deliverables to be included in the Human Factors Engineering / Usability Engineering (HFE/UE) report.
Bookmark(0)


Human Factors Planning 101


Learn more about the Human Factors Plan including a handy checklist of deliverables to be included in the Human Factors Engineering / Usability Engineering (HFE/UE) report.


Bookmark(0)

Helpful Links

Here are some of our favorite resources on this topic.


FDA Guidance on Applying Human Factors and Usability Engineering to Medical Devices


See how Human Factors and Usability Engineering processes can be applied into the development of medical devices and combination products.

Read More

FDA Draft Guidance Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development


Looking to develop a combination product? This draft guidance focuses on HF considerations related to combination products.

Read More

Role of Human Factors Engineering in Medical Products Regulatory Reviews and Research


A great overview of human factors in medical product development and evaluation.

Read More

Other Human Factors FDA Links


Read our blog that includes an extensive list of valuable Human Factors FDA links.

Read More 


Helpful Links

Here are some of our favorite resources on this topic.


FDA Guidance on Applying Human Factors and Usability Engineering to Medical Devices


See how Human Factors and Usability Engineering processes can be applied into the development of medical devices and combination products.

Read More


FDA Draft Guidance Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development


Looking to develop a combination product? This draft guidance focuses on HF considerations related to combination products.

Read More


Role of Human Factors Engineering in Medical Products Regulatory Reviews and Research


A great overview of human factors in medical product development and evaluation.

Read More


Other Human Factors FDA Links


Read our blog that includes an extensive list of valuable Human Factors FDA links.

Read More 


Experts

  • Successful track record of developing combo products using HF as a foundation from invention through commercialization
  • Regulatory Leadership from FDA CDRH and CDER/DMEPA with over 900 medical reviews and evaluations of medical devices and combination products
  • In addition to our experts, HURAS includes an experienced team of subject matter experts that have worked on numerous programs requiring human factors and usability engineering support for small, medium and large clients.


Michael Denzer Kymanox Human Factors (HURAS) Regulatory and Strategy SME

Michael Denzer

VICE PRESIDENT
TECHNICAL SOLUTIONS


EMAIL
michael.denzer@kymanox.com

MOBILE
+1 908.963.2701

QuynhNhu Nguyen Kymanox Human Factors (HURAS) Regulatory and Strategy SME
QuynhNhu Nguyen

DIRECTOR
HUMAN FACTORS


EMAIL
HURAS@kymanox.com

PHONE
+1 919.246.4896

Millie Shah Kymanox Human Factors (HURAS) Regulatory and Strategy SME

Millie B. Shah, PharmD, BCPS

ASSOCIATE DIRECTOR
HUMAN FACTORS


EMAIL
HURAS@kymanox.com

PHONE
+1 919.246.4896


Experts

  • Successful track record of developing combo products using HF as a foundation from invention through commercialization
  • Regulatory Leadership from FDA CDRH and CDER/DMEPA with over 900 medical reviews and evaluations of medical devices and combination products
  • In addition to our experts, HURAS includes an experienced team of subject matter experts that have worked on numerous programs requiring human factors and usability engineering support for small, medium and large clients.


QuynhNhu Nguyen Kymanox Human Factors (HURAS) Regulatory and Strategy SME
Michael Denzer
VICE PRESIDENT
TECHNICAL SOLUTIONS

EMAIL
michael.denzer@kymanox.com

MOBILE
+1 908.963.2701

QuynhNhu Nguyen Kymanox Human Factors (HURAS) Regulatory and Strategy SME
QuynhNhu Nguyen
DIRECTOR
HUMAN FACTORS

EMAIL
HURAS@kymanox.com

PHONE
+1 919.246.4896

Millie Shah Kymanox Human Factors (HURAS) Regulatory and Strategy SME
Millie B. Shah, PharmD, BCPS

ASSOCIATE DIRECTOR
HUMAN FACTORS


EMAIL
HURAS@kymanox.com

PHONE
+1 919.246.4896