北京百力诺思医疗器械科技有限公司

We have the FDA Regulatory consulting. 

• Establishment Registration and Device Listing
• FDA 510(k) Submission
• U.S. Agent
• FDA QSR Compliance

We can help in achieving ISO 13485 quality system compliance and CE marking.

• European Authorized Representative (EC REP)service.
• CE Marking Consulting
• Technical File/Design Dossier Preparation
• ISO 13485 Quality System Compliance

We assist your company to bring the products into the China market.

• CFDA Approval
• Regulatory Consulting
• Medical Device Standards Drafting
• Clinical Trial Development and Management

We can help in easy access into both U.S. and China medical device market:

• Market capability analysis.
• Distributors searching and qualification.
• Health care policy analysis.