REGULATORY AUDITING OF MEDICAL DEVICES

REGULATORY AUDITING OF MEDICAL DEVICES
Author(s):
Devanshi Brahmbhatt, Devang Tandel
Keywords:
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
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