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Design of Experiments, or DOE as it is commonly known in the industry, is defined as a “branch of applied ...
The Brexit has not only impacted Britain and the EU, it has made changes to the Northern Ireland region as well. As
Built and powered by data-intensive platforms such as Human-Computer Interaction (HCI), AI, Cloud Computing, Big ...
Homeopathic medicines have been around since the 1700s, and the premise behind them has not changed much in the ...
The EUDAMED Actors module is all set to start accepting registrations from member states and economic operators ...
Continuously growing elements of the Industry 4.0 are the bits and bytes, or data. With platforms like Internet of ...
It is no secret that brand-name drugs in America are often expensive. Luckily, for the many American’s who are not ...
Now more than ever, the Emergency Use Authorization (EUA) pathway for medical devices has become a popular topic. ...
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.
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