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.
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.
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
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
Insights
Infographic: Human Factors - Enjoy the Journey and the Destination!
Insights
Infographic: Human Factors - Enjoy the Journey and the Destination!
Human Factors Planning 101
Human Factors Planning 101
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.
FDA Draft Guidance Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development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.
Role of Human Factors Engineering in Medical Products Regulatory Reviews and Research
A great overview of human factors in medical product development and evaluation.
Other Human Factors FDA Links
Read our blog that includes an extensive list of valuable Human Factors FDA 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.
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.
Role of Human Factors Engineering in Medical Products Regulatory Reviews and Research
A great overview of human factors in medical product development and evaluation.
Other Human Factors FDA Links
Read our blog that includes an extensive list of valuable Human Factors FDA links.
- 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
VICE PRESIDENT
TECHNICAL SOLUTIONS
EMAIL
michael.denzer@kymanox.com
MOBILE
+1 908.963.2701
Millie B. Shah, PharmD, BCPS
ASSOCIATE DIRECTOR
HUMAN FACTORS
EMAIL
HURAS@kymanox.com
PHONE
+1 919.246.4896
- 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.
TECHNICAL SOLUTIONS
EMAIL
michael.denzer@kymanox.com
MOBILE
+1 908.963.2701
ASSOCIATE DIRECTOR
HUMAN FACTORS
EMAIL
HURAS@kymanox.com
PHONE
+1 919.246.4896