Systematic Study about the Audit of Medical Device
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Audit, Medical devices, Regulatory audits, Adverse effect
Abstract
In the field of Medical science and technology, the medical device section is one of the crucial parts and has tremendous effects on the healthcare sector. The medical device to save lives has a game-changing invention in the healthcare sector. That’s why efficacy and safety is a primary concern related to the use of medical devices. It is the primary expectation that the patients will experience the enhancement of treatment quality after using these gadgets. For this reason, regulatory acceptance is much needed, and each medical device manufacturer has to go through an auditing process. The quality process audit is beneficial to multiple stakeholders and it also assures the quality process methods and related standards as well as the outcome products. It also minimizes the adverse effects related to the use in the treatment process. In comparison between government and private auditing bodies, the government sector proves more costly in the purpose of conducting an audit. The auditing bodies are responsible to ensure product quality and meet up all regulatory compliance and standards. The approved regulatory bodies also have quality training expert members and having up to date rules and regulations backed up. In this article, various types and methods of auditing are mentioned which covers every part of the auditing requirements.
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References
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