what is the difference between iso 13485 and 21 cfr 820?

The quality management system for medical devices industry must meet regulatory requirements which mandate the manufacturers to design and develop medical devices that are safe and fit for their intended use. It enables you to drive the culture of continuous improvement in the organization without any hassle.Īs you know, the medical device manufacturing vertical is highly regulated industry. You can attain all the quality management principles for medical devices with Qualityze ISO 13485 Quality Management Software for Medical Devices has designed to align your company processes with the quality goals while complying with ISO requirements. This directly implies for improved productivity. The more will be your employees understanding of their roles to deliver quality product and services the more will be their engagement. When you will seek help from the employees to improve their own processes – they will not only provide the best insights, but also will be happier and more involved. This is a direct implication for increased revenue. Also, keeping customers satisfied will bring them back, and you will be able to sell your services to new customers. You need to achieve this principle by evaluating the needs and expectations of the customers and striving to meet them because today customers are more specific about their demands. One important principle highlights customer satisfaction. The ISO 13485 standard relies on certain quality management principles. You can also reduce the chances of errors in the process while fostering the greater efficiency in the organization and increase cost-savings. You can easily identify and eliminate the causes that could lead to rework and waste. ISO 13485 specifies organizations to use a process approach that makes it easier for you to identify new opportunities to improve. The added bonus here is an insight into your business health as you can track every improvement done and their results. What your instinct tells you will not always be right it can put you in serious business troubles at times. When you will use the data and facts to make informed decisions, you are likely to align them with your business objectives. This enables you to attract more opportunities.Īn important principle of quality management under ISO 13485 is that it focuses on evidence when it comes to decision-making. Makes a great marketing tool since it has become a requirement for medical devices suppliers to showcase compliance in many countries. With an ISO 13485 Medical Devices QMS software like Qualityze implemented in your organization, you can reflect trustworthiness for your clients and customers to do business with you. Improved Brand Recognition and Credibility

What is the difference between iso 13485 and 21 cfr 820?