Case Study 29 : Quality Audit and Preassessment before CFDA Inspection for a European CMO
The Client had network of 10+ manufacturing sites in 5 European locations with several development and distribution centers.
Case Study 28 : Registration of Class II Medical Device in Australia, Brazil, China, India, Pakistan and Russia
The Client is a US based medical device company that has registered its class II medical devices in USA, Canada and EU. Client wanted to get approval for its products in international markets
Case Study 26 : ISO 13485 Suppliers Audits in China for a Mexican Medical Device Company
The Client is a Medical Device Manufacturer based in Mexico, that wants to buy some medical device parts from suppliers in China.
Case Study 25 : Change of Local Agent, License Renewal for a Class II Medical Device in China
The Client is US based medical device manufacturer for orthopedic products, consisting of a of a cranial remolding orthosis that is a class II medical device.
Case Study 24 : Registration of a Software as medical device in China, Columbia and South Korea for European AI based Company
The Client is a US based medical device company that developed a suite of innovative AI based software for multiple applications.
Case Study 13 : New Drug Registration in USA, China and Japan
Client wanted to start the registration process in China and once approved in China they wanted to get registered in US and Japan in parallel.