DESIGN AND DEVELOPMENT CONTROL CONSULTATION FOR SOFTWARE AS MEDICAL DEVICE (SaMD)

No.	Task
1	Conduct regulatory pathway assessment and quality planning in accordance with US FDA SaMD regulations and recognized standards. Recommendations will be made regarding the following: Finalization of intended use and clinical indications; Analysis and evaluation of predicate devices or clinical diagnostic standard methods; Analysis and evaluation of hazards and risks related to the final software product; Service output: Regulatory pathway evaluation report and draft quality plan.
2	Regulatory training on: US FDA SaMD and regulatory guidances related to recognized standards Customized panel discussions and workshop Service output: Completion of 8-hour regulatory training.
3	Conduct and mock review of existing software design and development records: In accordance with the requirements of ISO 14971, IEC 62304, FDA medical device software verification and validation regulatory guidance, etc., conduct a mock review of the design and development records of the product, and propose regulatory compliance gaps, complete 1 copy of report; Provide improvement suggestions for relevant deficiencies as a reference for customers to implement design and development control of the medical software. Service output: Mock review report
4	Consolidation of software technical documentations which may include the following but not limited to: Algorithm acceptance benchmark evaluation and verification (combining clinical evidence classification and standard testing method evaluation); Evaluation and verification of product algorithm training models; Evaluation and verification of third-party software or database; Testing, verification and validation for the entire system of the software product; Counseling and pre-review of records at each stage of design and development (limited to 2 times); Service output:* Software technical file required for pre-market submission.