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Elexes Medical Consulting LLC
Our Mission is to help you get your product to the market and make them survive!
At Elexes Regulatory and Quality Compliance Consulting, we are a trusted name in the medical device regulatory industry. Beyond guiding clients through their regulatory journey, we are committed to keeping them informed and educated on all things regulatory. Through our Weekly Newsletters, we aim to provide you with essential updates and insights to help you stay ahead in the ever-evolving regulatory landscape.
So, let's see what we have for you this week.
In this blog, we have discussed key medical device labeling changes that require a new 510(k) submission, including modifications affecting safety, reuse, Rx to OTC use, new conditions, and patient demographics. It emphasises the need for thorough assessment and FDA approval for changes that may impact device safety and effectiveness.
This blog is essential for manufacturers to understand when a new submission is required, ensuring compliance and avoiding regulatory issues.
In this blog, we cover everything you need to know about medical device labelling, including its critical components, such as device identification, intended use, warnings, symbols, and multilingual requirements. We also explore different labeling types, like instructions for use (IFU) and packaging labels. Additionally, we offer practical tips to streamline the labeling process, helping ensure compliance, patient safety, and proper regulatory adherence.
For a comprehensive guide, read the full blog...
About Us
Elexes Medical Consulting is one of the reputed and trusted names in regulatory & quality compliance industry. Over the period of 5 decades, we have helped several companies get approval for their products. We deal in all kinds of medical device, IVD, SaMD, Wearable Device regulatory services.
To know more about us, you can check out the link below...