Do you Struggle Assessing Quality when it comes to FDA Human Factors Validations?
Can you use a domain-focused appraisal tool?
Manufacturers of medical devices and combination products are subject to regulations which impose on executive management the responsibility for establishing quality systems, including assessing the quality of suppliers in association to the level of risk involved (21 CFR 820.20). The human factors (HF) validation requirement has a direct impact on the quality of these products and (and of course, on approval to market).
I am a Ph.D. Candidate at Binghamton University in the School of Industrial and Systems Engineering, doing dissertation research on the topic of FDA HF validations for medical devices and combination products. I am currently working on the development of a cutting-edge and domain-focused tool to measure quality and facilitate the delivery of FDA HF validations within the demands of the quality system regulation (QSR), and your inputs are essential!
Your organization is invited to participate in helping add to the research in this area. If interested, please send an email to kmrojas@binghamton.edu no later than Tuesday, January 15th to receive details and instructions on how to participate. This is a pressing need, and the invitation will close on 01/15 or once the required number of participants is reached. Those who participate now will undoubtedly be ahead of the game in ensuring quality for this critical component in the development of medical devices and combination products. Don't miss out!
What is in it for you?
Participating organizations can benefit directly as a result of this research in the following way:
- If you are an FDA human factors service provider, you will receive a free report at the end of this research, detailing your level of excellence (quality) in the delivery of FDA HF validations and any areas of improvements (to get you to the desired level). Further, you could be part of a database which will be available to procurers of FDA HF services.
- If you are an FDA human factors service procurer, you will gain valuable insight into how to better assess and control these critical suppliers. Most importantly: you could have access to a curated database of FDA HF validation providers which will facilitate complying with the stated regulatory requirements and ensure quality in product development!
The study involves an anonymous survey, and all data will be kept confidential. Only the principal researcher (Katia Rojas) will have access to the collected data.
Please feel free to share with others who may be interested!
I look forward to hearing from you,
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Katia Rojas, MS, PMP
Ph.D. Candidate
Binghamton University
kmrojas@binghamton.edu
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