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On July 4th 2025 President Trump signed in the One Big Beautiful Bill Act into law. This legislation is sweeping legislation that impacts all aspects of the United States. However, there are major impacts coming to employers and payroll departments across the ...
What are the basics of an enterprise maintenance-focused Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001, the international standard for Quality Management Systems for all business or industri ...
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation and how to use ISO62304 to establ ...
Any document, media piece, or email bearing your organization’s insignia or name must be absolutely error-free. Even a careless mistake in an email can damage a leader’s reputation and can make an entire company look bad. Proofreading is a skill anyone can lea ...
Whether in an informal setting or a more formal presentation, we all want to bring our “A Game” any time we speak up in a meeting or express our ideas. Plan to join us if: Quite frankly, you hate public speaking You’ve been embarrassed because you get shak ...
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulatio ...
Recovering wage overpayments can be a time-consuming and sometimes challenging process for payroll professionals. Accuracy is an essential element in the payroll process, but error-free payrolls are rare. State laws governing the recovery of overpayments and a ...
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the ef ...
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when new products are to be marketed in the U.S., or when existing products and/or their Indic ...
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are us ...