Team
Tim Follrath
Consultant
Tim Follrath has over 18 years of experience as a Human Factors engineering leader. He has managed the implementation of human-centered design strategies between integrated product teams, with specific regard to research planning, development, design & testing of new and legacy systems. Tim has worked within the bio-pharmaceutical, media research and aerospace industries. Tim is currently focused on collaborating with medical device companies to ensure human factors design processes are being applied towards the development of safe and effective combination products. He is highly skilled in creating usability plans, task analyses, instructional and training materials, research protocols, final reports, technical assessments, user risk mitigation assessments, usability engineering file summaries, regulatory documentation and responses to questions from the FDA. Tim is accomplished in the design and execution of formative and summative testing, which guide usability of the devices and ultimately validate the final product.
Academic & Professional Qualifications:
- BA, Psychology – California State University, Northridge
- MA, Human Factors and Applied Psychology – California State University, Northridge
- Systems Engineering Certificate Program – California Institute of Technology
- Certified Usability Analyst – Human Factors International
Training, Quality Systems, & Specialties:
- Collaborative Institutional Training Initiative (CITI)
- Health Information Privacy/Security (HIPS) for Investigators, Dec 2019
- Good Clinical Practice, Dec 2019
- Human Subjects Research – IRB Member, Dec 2019
- Social & Behavioral Research, Jan 2019
- Understanding of Medical Device and healthcare regulations including FDAs guidance’s; Applying HF/UE to Medical Devices, Design Considerations for Devices Intended for Home Use, Quality (21 CFR Part 820.30) and standards (e.g., ISO 13485, 14971, IEC 62366-1, ANSI/AMMI HE75:2009 (R) (2013).
- Proficient in Enterprise Document Management Quality systems such as EDMQ & EPIC, requirements management, defect tracking and peer reviews tools such as DOORS, Jama Contour and Sherlock.
- Practiced in the use of various Industry, government and military human engineering design guidelines/standards, (e.g., Human Factors Design Guide for Commercial-Off-The-Shelf Subsystems, Common Display Performance Requirements for Military and Commercial Aircraft, MIL-STD-1472, MIL-STD-1787, MIL-STD-3009, MIL-STD-46855, SAE ARP-4102/8, ISO 7250, ISO 9241-210:2010, IEC-60073 & UL-60950).
