This is the first of the series of posts regarding the ISO 17025 and accreditation. ISO 17025 specifies the management and technical requirement to be met by testing and calibration laboratories. Accreditation of the laboratories is usually performed by national accreditation bodies which usually has Mutual Recognition Agreements between other national bodies. The accreditation will …
Author Archives: Venkatesh
A Look at the Evolution of Quality throughout History
The concept of quality has evolved throughout human history, with various methods being used to ensure the quality of products and services. The Industrial Revolution marked a shift in the way quality was viewed, with a focus on meeting specifications rather than customer satisfaction. The Japanese quality revolution, the rise of consumerism, and the importance of standardization, such as the ISO 9000 series of quality control systems, have all played a role in the modern quality landscape.
Quality Improvement Projects – Getting the Top Managements Approval
Quality improvement projects are a great way to improve the quality of an organization’s products and services. Quality management during the period from 1980s to 1990s shows that the involvement of the upper management in quality projects plays a vital role in the quality improvement. To gain top management approval for quality improvement projects, it is important to present a clear and compelling case.
Clinical Performance Evaluation for new In Vitro Diagnostic Medical Device
The permission to conduct clinical performance evaluation for new in vitro diagnostic medical device can be obtained by a sponsor on submitting an application in Form MD-24 to the Central Licensing Authority, along with a fee prescribed in the Second Schedule and the required documents. If the application complies with the statutory requirements, then the …
Continue reading “Clinical Performance Evaluation for new In Vitro Diagnostic Medical Device”
Clinical Study of Medical Devices
The procedure to obtain permission to conduct clinical investigation of investigational medical device and the conditions to be complied with.
Medical Devices (Amendment) Rules, 2020
The Medical Devices (Amendment) Rules, 2020, was effective from 01st April 2020. Introduction of a new chapter namely, Chapter IIIA, which deals with the registration of medical devices, and the modification of Eight Schedule, were the major amendments made to the existing rules. A major modification in the definition of the Medical devices was also …
Medical Device – Modified Definition
On 11th February, 2020, the Ministry of Health and Family Welfare, Govt. of India published a gazette notification namely S.O. 648(E), which puts the definition of medical devices on par with the definitions of rest of the world. This notification is effective from 01st April 2020. You can go through the earlier definition here. In …
Labeling of Medical Devices from the standpoint of GMP / QMS
The labeling of the medical devices are discussed from the stand point of Good Manufacturing Practices and Quality Management system. It describes about the label content development and label control.
Labeling of medical devices – Medical Devices Rules 2017
Labeling of medical devices as mentioned in the medical devices rules 2017 for provided in a concise manner along with a little bit of descriptions and explanations.
Import of Medical Devices for Test or Clinical Investigations
This blog post explains the import of medical devices for test, evaluations, clinical investigations. Import of investigational medical device by Government Hospital, import of medical device for personal use etc.