Jeyadevi Rajesh
Member since: Jan 10, 2016
Published articles: 4
Surgical Sutures are medical devices that are used to hold body tissues together after a surgery or injury. These are used in conjunction with needles which may be varying based on their geometry such...
ISO 13485 represents the requirements for laying down a comprehensive Quality management system for the Design and Manufacture of Medical Devices. It is basically an all-encompassing standard that...
Most Medical device manufacturers, other than class I (non- sterile) who wish to place their devices in the European Union must as a first step identify a Notified body (NB) for certification and...
Medical Devices have a specific life time and it is the responsibility of each manufacturer to make sure the device performs its intended use during this period. So, Regulatory Bodies are concerned...
Author Bio
Jeyadevi Rajesh is a regulatory specialist at I 3 Consulting, a leading firm specialising in CE and Fda submssions. Contact jr@i3c.com for further information.