What Are The Key Points For The Product Research Documents Of The IVD Equipment?

To prepare the product research documents, attention should be paid to the following aspects:

1. Documents for the product performance research: mainly about the research of product technical requirements and preparation instructions, which should include performance study and safety study (electrical safety and electromagnetic compatibility) specified in product technical requirements.
2. Documents for the research of each clinical functional module: such as temperature control module, optical detection module, sample addition module, circuit control module, etc.
3. Documents for the machine performance research: mainly about the analytical performance research data of the analytes to be detected on the machine. It is recommended that the applicants choose one or more representative items for every class of analytes to do the performance research using clinical samples. When choosing the representative items to do the research, it is recommended to consider the overall situation of the target analytes and the main functions of the product according to the principle of the most unfavorable condition for evaluation.
4. Documents for the environmental test.
5. Documents for the study on the product expiry date and packaging.
6. Software research documents, including software description files and network security description files.
7. Documents for the other applicable performance studies that should be focused on based on design characteristics of the product.