Role of ISO 13485 in the Health Sector

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The health sector depends largely on the most modern medical devices. Therefore, any compromise on the quality and safety of medical devices is simply impossible. A medical device could be an instrument or a machine, an implant or an in vitro reagent used in medical institutions for the diagnosis, prevention, and treatment of any medical disease or condition. ISO 13485 is an internationally accepted ISO standard that establishes the requirements for quality management systems by ISO 13485 Consultant that are specific to the medical device industry. This includes organizations that design and develop, manufacture and are providers of medical device installation and medical device consultant, as well as the manufacturers of their members or materials.

Organizations in the medical device industry need to adhere to strict quality practices throughout the product cycle of the medical device. The main objective of ISO 13485 is to enable the requirements of the quality management system synchronized within the medical sector. The standard was first published in 1996 and, more recently, the improved version was published more recently in 2016. ISO 13845: 2016 is more proactive in the latest QMS practices and responds to changes in the latest technology. The new version also places more emphasis on risk management, as well as the acceleration of regulatory requirements for organizations in the medical sector supply chain.

Your organization's compliance with ISO 13485 can help open the doors to national and international business opportunities along with benefits such as:

1) Access to market expansion: medical device regulatory affairs strongly prefer manufacturers who have a third-party certified management system to market medical products in their countries. Investing in such a QMS accelerates entry into those countries that demand the same and facilitates market entry in others.

2) Cost savings: With the ISO 13485 certification, your company demonstrates confidence and commitment to quality. Because of the slow process of explaining the details and demonstrating the effectiveness of your quality system is effortless, it takes less time to gain the credibility and trust of your potential customers. It also saves on costs by minimizing product failures at the start stage.

3) Overall performance: Based on a consistent and universally accepted process control standard, your company's certified management system helps you radically improve your products and services. This can promote harmonious relationships with your partners, suppliers, and customers while offering you a competitive advantage in the market.


Location: Florida, USA

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