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The US FDA’s Center for Devices and Radiological Health (CDRH) announced a new pilot program that will allow the ...
In this webinar, we will be covering what exactly an SaMDs, or Software as a Medical Device, and go over some examples with Artificial Intelligence. We will also look at Artificial Intelligence and Machine Learning versus the traditional software. Next, we will go into the regulatory framework for these types of software, then explain how EMMA International can help you get your SaMD to market.
In this second part of the webinar, we will review how to tackle changes that were made to the software post market, the verification and validation activities for your software, regulatory clearance of changes made to the software post market, and how to handle software recalls.
This webinar will explore the Medical Device Single Audit Program, or MDSAP. We will provide an overview of the program, including how the audit is conducted and what regulatory requirements are included. We will also explore what the MDSAP audit could mean for your business as far as marketing options in other countries, as well as compliance risks to medium and small size companies. Finally, we will review lessons learned with real-life (i.e. field) examples to help you understand and prepare for the audit.
One of the paradigms of the next generation computing tools is Augmented Reality (AR) where animated objects are ...
Few people outside of the industry know how big of a role the FDA has in product labeling and packaging. Every ...
The De Novo pathway establishes new classification categories for novel low-to-moderate risk devices, which in ...
Imagine a platform where innovations meet modern healthcare services while following regulatory requirements. Such ...
FDA recently released a proposed rule that amends its existing regulations around establishing the intended use of ...
One of the major pillars of the current Industry 4.0 is Automation. Indeed, technology is intervening in almost ...
Programmable Logic Controllers (PLCs) are the components that are used for interfacing between multiple hardware ...
Medical device manufacturers are responsible for not only developing safe and effective devices, but also ensuring ...
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