Blog Category: Standards

Color Additive Petitions

September 24, 2021
Standards

FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices Food and Drug Administration (FDA) provides guidance for the...

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Safety and Performance (SSP) of Class C and D IVDs

September 1, 2021
Standards

The Regulation (EU) 2017/745 on medical devices requires that the manufacturer shall draw up a summary of safety and clinical performance (SSCP) for implantable devices and for class III devices, other...

SaMD Regulatory Landscape in the US and Europe

August 13, 2021
Standards

Software as a medical device (SaMD) has emerged as a class of devices for collecting, processing and analyzing healthcare data to manage disease. Powered by analytics, SaMD accelerates the diagnosis...

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Clinical Trial Management Guidelines under Covid-19 – Europe

June 9, 2021
Standards

Good Clinical Practice (GCP) is referred to an internationally acclaimed ethical and scientific quality standard for designing, recording and reporting trials involving participation of human subjects....

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FDA Warning Letter Jan-Apr 2021 Recap Summary

May 6, 2021
Standards

Warning DescriptionProducts & SummaryFDA has seen manufacturer’s Website and their claims on products, as per that they fit in the definition of the devices and has not taken approval or clearance...

The US FDA handed out 15 warning letters in March to manufacturers of various products that were unapproved to mitigate or prevent COVID-19.

Regulatory Intelligence is a key to Quality and Safety

January 29, 2021
Standards

Organizations often face unforeseen risks when they tread on the uncommon roads of the life science sector. They are often termed as in compliance or compliance issues, which has a direct impact on...

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