In this webinar hosted from EMMA International’s Manager of Technical Operations, Madison Wheeler, she gives a walkthrough of what to expect from an FDA inspection of your facility, plus the “do’s and don’ts” of regulatory inspections.
In this webinar hosted from EMMA International’s Software Engineer, Govind Yatnalkar, he focuses on the recently released FDA’s action plan for regulating AI/ML-based software as a medical device (SaMD). He then dives into the five major action items provided in the action plan along with examples that define the actual regulation strategies for AI/ML-based SaMDs.
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 device listings.
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.
Are you a manufacturer and want to help with the COVID-19 Pandemic? We invite you to attend our upcoming webinar to learn more about FDA’s temporary policies for regulating Personal Protective Equipment (PPE), Reprocessing, Ventilators and Hand Sanitizer manufacturing, and what you need to do to get your product on the market.
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 Sr. Quality Engineer Matt Ward explains how to build a strong Design History File for your product by incorporating human factors engineering into the design controls and risk management plan for your product. Learn how risks can be mitigated in the early stages of product development by integrating HFE into the design of your product.
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 you should include in your pre-market submission.
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.