Audit, Auditing phases, Clinical trials, Medical devices, Regulatory audits
Abstract
Medical devices are a crucial part of the healthcare sector, as they are used to save lives. That is why it is so important to keep them safe. Patients expect the gadgets they are using to enhance their quality of life, thus demonstrating regulatory compliance is crucial. Each medical device producer goes through thorough quality audits conducted by the regulatory organizations as part of the auditing process. They ensure that the producers are producing high-quality goods following the set standards. Even the approved auditing bodies and the organization being audited must possess a high level of training, expertise, and adherence to several rules and obligations. Various types and methods are mentioned in this article, which covers every part of the auditing requirements.
Article Details
Unique Paper ID: 156311
Publication Volume & Issue: Volume 9, Issue 3
Page(s): 247 - 254
Article Preview & Download
Share This Article
Conference Alert
NCSST-2023
AICTE Sponsored National Conference on Smart Systems and Technologies
Last Date: 25th November 2023
SWEC- Management
LATEST INNOVATION’S AND FUTURE TRENDS IN MANAGEMENT