DreamCIS is ready to help set up any strategies that lead successful outcomes in any markets home and abroad, depending on the medical device markets.
Now is the time to fully and accurately understand fierce competition for the medical device development, the regulatory requirements, and the product management during the life cycle of the products. In this light, DreamCIS retains the international resources and the knowledge about the local regulatory requirements to ensure effective strategy preparation for approval.
DreamCIS have engaged highly skilled professionals for medical device in offering the service for innovative and successful outcome to meet the client’s needs and the regulatory requirements.
- Consulting about good quality strategy for the development of device and combined product
- Preparation for customized regulatory submission
- Communication and meeting with the regulatory authorities at all phases of the development
- Import and export consultation for development of global device
- Inspection to evaluate regulation compliances
- Post-approval/post-authorization support registration and post-approval studies to maintain safety, efficacy and performance