As a requirement within ISO 13485, the management must ensure that adequate resources are available to perform continuous work by the organization. Providing resources can refer to personnel, infrastructure, consumables, equipment, etc. Human resources In this part, the standard focuses on the improvement of human…
Work environment and contamination control are important and critical for effective and compliant medical device business run. Definition of the Working Environment Work conditions and environments must be under effective control. And by the ISO 13485 standard, it undoubtedly means, it must be documented as…
Naturally, planning goes ahead of realization. And this part of the standard explains how important is for you to be consistent in planning throughout all parts of your quality management system. Plus, it refers to all phases of the life-cycle of your medical device. Quality…
Depending on the medical device type you can assume who are potential users of the same. After you define that, you will easier understand this chapter of ISO 13485. Determination of the requirements related to the product There is a standardized method to identify the…
The design and development of the medical device are one of the most crucial parts of the ISO 13485 standard due to its complexity compared to other industries. The design and development process for medical devices has to deal with product safety, risk controls, relevant…
In the medical device industry, it’s not just purchasing. ISO 13485 standard has some strict rules when it comes down to purchase from suppliers. The main factors that influence this process should be addressed, and the main suppliers. ISO 13485 requires you to document your…
ISO 13485 standard intends to cover a wide range of manufacturing, therefore, it’s a bit generalized when it comes to defining applicable requirements and service provision processes. This section of the standard might be confusing for many, but we will try to divide it down…
The ISO 13485 standard treats monitoring and measuring devices very seriously. Every medical device company must have had plenty of various equipment for measuring and monitoring. According to the ISO 13485 Standard, they are considered as an important element of the realization process. Therefore, the…
Your medical device and its quality process must be measured, monitored, analyzed, reported, and reviewed. It’s done by using a system of measurement-analysis-improvement that is designed to strategically manage the ‘quality’ of the Quality Management System (QMS). The processes that ensure the effectiveness of the…
What mostly reflects the effectiveness of the Quality Management System is monitoring and measurement focus on the quality of your medical device. The ISO 13485 Standard defines several sections in which monitoring and measurement should be emphasized highly addressed. Feedback The ISO 13485 Standard requires…
