Apr 22, 2022
FDA
The new article describes in detail the content of the submission in terms of quality system information and also highlights the aspects related to the design control information. Table of Contents The Food and Drug Administration...
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Apr 19, 2022
FDA
The article provides an overview of the regulatory framework related to the quality system information and highlights the most important aspects associated thereto. Table of Contents The Food and Drug Administration (FDA or the...
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Sep 6, 2019
Uncategorized
What Is It? ISO 13485 is a quality management system that is used internationally. It controls safety in work environments, risk management, and design, and creates requirements for inspections, documents, procedures, and verification of safety and effectiveness of...
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May 11, 2016
Consultant Post
China has become the second largest medical device market in the world. Sustained economy, population growth and a burgeoning aging population makes China a lucrative market for foreign medical device and pharmaceutical manufacturers. Nevertheless, China is considered...
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Oct 21, 2015
RegDesk News/Info
Maria is a regulatory consultant and expert on registrations in Mexico. She has been a medical device consultant with RegDesk for awhile and we recently had the chance to speak about her experience with us! REGDESK: What has been your experience with RegDesk so...
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