Main content of MDD
Main content of MDD including:
1. Must be safety;
2. Design and produce must according to the technology which have gained approval currently;
3. The expected performance must be achieved;
4. The utility and security of the products must be ensured within lifetime;
5. Regulations regarding transportation and storage requirements must be worked out;
6. Side-effect must within an acceptable range;
7. Traits of Chemistry, physics and biology like toxicity, biocompatibility and so on must within an acceptable range;
8. Infection and microbial contamination must within an acceptable range;
9. The environment effect like EMC and so on must be considered when combining other devices.