An Introduction To Human Factors and Usability Validation Tests – ISO 62366
What is Human Factors and Usability Validation? FDA uses human factor and usability validation guidance document to assist studies how people interact with systems. Medical device manufacturer, pharmaceutical concern producing a drug delivery system such as an injector or inhaler, follow appropriate human factors and usability engineering processes. Human factor studies play an integral role […]
7 Keys to Achieving Compliance Excellence – An article by Charles H. Paul
Key#1: Understand the regulations that pertain to your industry and your business throughout each level and function of your organization This is more difficult than it appears because Federal Regulations are simply not prescriptive and that is by design. 21CFR 820 Medical Device QSR for example, must be applicable to both manufacturers of small surgical […]
HIPAA : HHS & PHI, 2017 Updates, Security Rule, Penalties & Violations
The Privacy Rule issued by U.S. Department of Health and Human Services (“HHS”) Goal – strikes a balance between protecting individuals’ health information and allowing/permiting the flow of health information needed to provide quality health care. Regulates – address the use and disclosure of individuals’ health information – called “protected health information” by organizations subject to the […]
Compliance Changes in HIPAA 2024
Introduction HIPAA has evolved to keep pace with advancements in technology and healthcare practices. 2024 introduces significant compliance updates to enhance the protection of health information. This article outlines key changes and their implications for healthcare providers, business associates, and patients. Enhanced Cybersecurity Requirements New Standards for Encryption:Advanced Algorithms, required for data at rest […]