– Registration clinical pathway planning
– Output of regulatory standard list, regulatory compliance evaluation
– Preparation of product technical requirements
– Confirmation of third party commissioned testing and design & validation plan
– Clinical trial application and clinical trial filing of high-risk medical devices
– Preparation and application of registration materials, and technical communication with the evaluation department

– Patent, innovative content sorting, application strategy planning, pre-application guidance
– Preparation and application of materials, communication with the evaluation department, etc.

Identify the product classification and application pathway, compare with the existing 510(k) products close to the product, communicate and coordinate with the FDA, and complete the product application according to the De novo application pathway

Communicate product clinical evaluation strategy, clinical trial protocol content with notified body

Application for approval of premarket clinical trials by authorities in EU countries

-Identify the product classification and attribute definition as well as application
-Research on regulations, review requirements and quality system requirements
-Assist in background checks and evaluate registration pathways for potential collaborative projects
-Communication and consultation with regulatory authorities
-Pre-review of registration material

-Maintenance of registration certificate
-Change of control and change of judgment
-Warning system maintenance

-Application and maintenance of other types of certificates
-Risk management, biological evaluation requirements and regulatory support
-Regulatory training