Profile

Katia Rojas, PhD, PMP

Contact Details

United States

Contributions

1 to 3 of 3 total
Posted By Katia Rojas 10-Feb-2019 12:00
Found In Egroup: Regulatory Open Forum
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Be part of a select group/panel of experts who will be providing anonymous inputs in the development of an industry assessment tool (specific to the field) for FDA human factors validation projects! The tool will primarily help: Measure and increase the quality of the indicated projects. Enable ...
Posted By Katia Rojas 15-Jan-2019 05:39
Found In Egroup: Regulatory Open Forum
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Dear medical device/combination products manufacturers, There is still opportunity to participate! Medical device/combination products manufacturers, organizations that procure or provide human factors services for FDA validations, contact me for more details! ------------------------------ Katia ...
Posted By Katia Rojas 04-Jan-2019 14:18
Found In Egroup: Regulatory Open Forum
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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 ...