FDA has issued a proposed rule to up classify surgical staplers for internal use as class II medical devices, subject to special controls and pre-market notification. Currently, both internal and external surgical staplers are classified as class I, subject to...
Ensuring you have a robust Quality Management System (QMS) is the first step in maintaining compliance with both FDA and ISO regulations and requirements. A good software-based quality management system can make the process much easier. A paper-based or multi-software...
China is considered to be one of the many booming medical device markets with its continually increasing innovation potential and high market demand. In 2016, China’s medical device industry achieved a total sales revenue of 244.8 billion yuan, an increase...
It seems like everyone and their dog are using products containing CBD, but are they safe, effective, and in compliance with the Food, Drug, and Cosmetic (FD&C) Act? A hearing was held on May 31 to discuss just that. Many...
India’s medical device market is growing exponentially. The medical device industry in India is presently valued at $5.2 Billion and is growing at 15.8% CAGR. Currently, India is considered among the top 20 global medical device markets and is the...
With the continued advances of Artificial Intelligence and Machine Learning (AI/ML), we are at the forefront of a new medical device era. In our previous blogs AN UPDATE ON FDA’S DIGITAL SOFTWARE PRE-CERTIFICATION PROGRAM and MODIFICATION AFTER INITIAL REVIEW AND...
Are you working with a product whose fitness for use or quality deteriorates over time? Does your Quality Management System support identification and controls of products storage and distribution requirements between following manufacturing and until placed in-service? The Quality Management System...
With less than a year until the end of the EU MDR transition period, it is pertinent to ensure that all devices to be sold in Europe comply. We’ve been highlighting many of the new requirements in our blogs, including: INTRODUCTION...
FDA defines data integrity as the completeness, consistency, and accuracy of data. Data Integrity is not a new concept and it has been a matter of concern since the paper and ink era. With the new computerized systems and cloud...
Post-Market Surveillance (PMS) is required for medical devices. There are two types of post-market surveillance – reactive and proactive. Reactive is the most common approach used when setting up a PMS system, but that doesn’t mean a proactive approach isn’t...