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
Article Preview & Download


Share This Article

Conference Alert

NCSST-2021

AICTE Sponsored National Conference on Smart Systems and Technologies

Last Date: 25th November 2021

SWEC- Management

LATEST INNOVATION’S AND FUTURE TRENDS IN MANAGEMENT

Last Date: 7th November 2021

Go To Issue



Call For Paper

Volume 8 Issue 4

Last Date 25 September 2021

About Us

IJIRT.org enables door in research by providing high quality research articles in open access market.

Send us any query related to your research on editor@ijirt.org

Social Media

Google Verified Reviews

Contact Details

Telephone:6351679790
Email: editor@ijirt.org
Website: ijirt.org

Policies