Webinars

In this webinar hosted from EMMA International's Lead Quality Engineer, Nikita Angane, she will go over the different FDA Centers, as well as the pathways to market, what a RTA (Refuse to Accept) is, and also reviewing labeling, registration, and...

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,...

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,...

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...

Our Lead Quality Engineer, Nikita Angane, explains how to build a strong Quality Management System for your Software as a Medical Device....

Our Quality Engineer, Madison Wheeler, discusses the characteristics of an efficient product development process for medical devices and how medical device product development should incorporate Quality, Regulatory, and Business needs in parallel....

Our RA Manager Song Seto guides you through the FDAs pathway to get your combination product to the US market. Learn more about the combo products pre-market submission reviews and the other mechanism devised by the FDA and things that...

EMMA’s EMEA Regional Director Joseph Yammine explains how the EU’s General Data Protection Regulation applies to the Health Care Industry and how you can prepare your team to follow the regulation and avoid any data breaches....