by Sarita Ranjan | May 21, 2021 | Medical Devices
Class I devices are the lowest risk medical devices. However, the manufacturers of these devices also need to act immediately to comply with the new European Union (EU) Medical Devices Regulation (MDR); otherwise, they risk being unable to place their devices on the...
by Varsha joshi | Sep 15, 2020 | Medical Devices
Background According to European Commission a web-based portal EUDAMED is being developed to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. The system consists data on medical devices that have...
by Namrata Singh | Aug 6, 2020 | Medical Devices
Background The COVID-19 outbreak is a public health crisis that this generation has never seen before and has presented itself as an unprecedented challenge to the health industry including the Medical Device and Regulatory framework. There is tremendous burden being...
by Anupama Singh | Aug 24, 2018 | Medical Devices
When a device seems to fit onto the definitions of two or more product types, and cannot be clearly classified as a medical device, an in vitro diagnostic medical device, or an active implantable medical device, it is referred to as a borderline medical device. The...
by Anubhav Mehra | Mar 19, 2018 | Medical Devices
Introduction Medical device is an essential part of healthcare system. It is utilised for diagnosis, prevention and treatment of the disease as well as for patient care. It covers a broad range of products, starting from simple bandage to drug delivery pumps. Over the...
by Anubhav Mehra | Mar 14, 2018 | Medical Devices
Introduction Drug regulations can be defined as the overall control of drug by following rules and regulations which are enforced by the government to protect the health and well-being of humans. They are crucial for ensuring high quality of the drug by confirming its...