1、SubmissionType
2、Cover Letter / Letters of Reference
3、Submitter Information
4、Pre-Submission Correspondence & PreviousRegulator Interaction
5、Consensus Standards
6、Device Description
7、Proposed Indications for Use (Form FDA3881
8、Classification
9、Predicates and SubstantialEquivalence34
10、Design/Special Controls, Risks to Health, andMitigation Measures
11、Labeling
12、Reprocessing
13、Sterility
14、ShelfLife
15、Biocompatibility
16、Software/Firmware
17、Cybersecurity/Interoperability
18、Electromagnetic Compatibility (EMC), Electrical,Mechanical, Wireless and Thermal Safety
19、Performance Testing
20、References
21、Administrative Documentation
22、Amendment/Additional Information (AI)response
深圳思博达医疗技术服务有限公司凭借500余个医疗器械注册认证成功案例经验，为国内外医疗器械公司，科研机构、个人提供二、三类医疗器械注册证办理，二、三类医疗器械生产许可证办理，二类器械经营备案证、三类器械经营许可证办理，注册人研发、委托生产、一类产品备案证、一类产品生产备案证、产品注册检验、临床试验CRO、医疗器械质量体系GMP现场考核、ISO13485质量管理体系、、软件管理，三品一械（食品、药品、化妆品、医疗器械）法规标准培训、CE和FDA等“一站式”服务等等。
