1. Propose the function, performance and safety requirements of the product as required.

2. Collect laws and regulations for use.

3. Collect relevant information about similar products for comparison.

1. What is the current level of technical level of such products in China, the forward-looking technology and whether it is the current or future mainstream treatment;

2. The domestic approval of similar products;

3. What is the hospital access situation for this type of product, whether it is restricted, and how extreme the future will be;

4. The feasibility and time limit for obtaining the approval documents in China; whether there are intellectual property rights and patent restrictions;

5. The possibility of accepting localized hospitals for such products.

1. Sterilization verification

2. Validity period verification

Design a scheme of valid verification and assist corporate to accomplish it.

3. Software verification includes software code review, design review, development of test plans and reports

4. Relevant safety verification and improvement during product testing.

1. What is the current level of technical level of such products in China, the forward-looking technology and whether it is the current or future mainstream treatment;

2. The domestic approval of similar products;

3. What is the hospital access situation for this type of product, whether it is restricted, and how extreme the future will be;

4. The feasibility and time limit for obtaining the approval documents in China; whether there are intellectual property rights and patent restrictions;

5. The possibility of accepting localized hospitals for such products.