In recent years, China has issued a series of policies successively to deregulate innovation, encourage and support R&D of innovative medical devices, including Opinions on Deepening Review and Approval System Reform and Encouraging Drug and Medical Device Innovation, and the Notice on Extending Pilot Work of the Medical Device Registrant System. Tigermed-Jyton is experienced in providing services on innovative medical device R&D and can provide regulatory and system services at the product design and development stage.
• Design of product launching strategies (product development consulting report)
• Establishment of the design & development quality system
• Input and output support at the design and development stage
• Product verification and validation design
• Technical document guidance
• Design transformation guidance
• Regulatory input and guidance