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Regulatory Support
Published:2022-11-13 11:44:11 Share:

CE-marking

Are you a manufacturer of medical device and/or in vitro diagnostic medical device?

 

Do you have plans to enter into German/EU market?

NIC team would be happy to provide you regulatory support on CE marking and EU authorized representative service.

 

NMPA, Registration NMPA

With extensive medical resources in China and a leading team of medical experts, NIC is able to provide regulatory service for registration and approval with NMPA, China.

 

Our team will:

Assist the manufacturer to determine product classification

Determine the applied standards and test requirements

Prepare technical documents or design materials, or review your existing documents.

Review existing marketing materials, labels and user instruction information to ensure compliance and consistency

Verify compliance with essential requirements

Prepare clinical/performance evaluation report based on the provided clinical data

Implement, revise and maintain a quality management system that can meet European and other international requirements (usually ISO13485)

Risk analysis and management (ISO 14971)

Develop vigilance system and post-marketing monitoring procedures

Provide EU authorized representative services to the manufacturers that do not have a physical office in Europe

Support the manufacturer to communicate with Notified Body


Contact US

E-mail:info@nic-industry.com Website:www.nic-industry.com Add:Erlenweg 13,49076 Osnabrück Germany