Resource Center

Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory in the life science industry.

Building a QMS for Your SaMD – Part II

In this second part of the webinar, we will review how to tackle changes that were made to the software post ...

MDSAP – What it Means to Your Business

This webinar will explore the Medical Device Single Audit Program, or MDSAP. We will provide an overview of the ...

Applications of Augmented Reality in Medical Devices

One of the paradigms of the next generation computing tools is Augmented Reality (AR) where animated objects are ...

The Importance of Packaging & Labeling Regulations

Few people outside of the industry know how big of a role the FDA has in product labeling and packaging. Every ...

Analyzing De Novo Devices

The De Novo pathway establishes new classification categories for novel low-to-moderate risk devices, which in ...

The FDA’s Digital Health Center of Excellence Platform (DHCoE)

Imagine a platform where innovations meet modern healthcare services while following regulatory requirements. Such ...

Deciding The Intended Use Of The Product Under FDA

FDA recently released a proposed rule that amends its existing regulations around establishing the intended use of ...

Understanding Cybersecurity in Medical Devices and Applications

One of the major pillars of the current Industry 4.0 is Automation. Indeed, technology is intervening in almost ...

Meeting FDA Regulatory Requirements While Programming PLCs

Programmable Logic Controllers (PLCs) are the components that are used for interfacing between multiple hardware ...

Medical Device Post-Market Surveillance Requirements

Medical device manufacturers are responsible for not only developing safe and effective devices, but also ensuring ...

Medical Device Databases: FDA’s Backend Platforms for Medical Devices

Data is the single most vital entity of any system and therefore, data storage and management become some of the ...

Decision Forests: FDA’s Tool for Data Analysis and Pattern-Recognition Methods

Decision Forests (DFs) are one of the most aggressive data classifying AI algorithms. A decision forest comprises ...