Core algorithm:
In fact, the first registration for medical device software should list out the names, principles, usages and styles of all core algorithm. The actual re-registration should list out the ones that are new added.
Canned software:
For partial methods of canned software, the declaration requirements of outsourcing, finished products and reserve software must be the same, which is explained in details in the former chapter. The declaration requirements for methods of wholly canned software are as follow:
1. Outsourcing software should provide outsourcing contract and software described documents
2. Finished software should provide outsourcing contract and software described documents.(content which is not suitable must explain) eg: products enter Chinese market should provide copies of product registration and relevant materials.
3. Reserved software should provide copies of product registration and software described documents.
Osmunda can provide fully solutions of medical devices from product design, clinical trail, product testing, clean workshop design construction to enterprises registration (Production license/product registration certificate/business licenses), International registration of product (European Union, The United States, Canada, Japan, Australia, China and other places) . So far, we've helped over 1000 national and international enterprises to get different kinds of professional certification. Osmunda has signed up with many famous national and international medical device groups for long-term agreement of outsourcing audits and consulting service,
