Wir werden Hersteller von Medizinprodukten von Design, Entwicklung bis zur Zulassung und Post Market begleiten. Das Service vom regulatory affairs ist vom kritischen Markt wie China, US, EU zu Taiwan, ASEAN –Länder und MDSAP-Länder. Darüber hinaus haben wir Workshops, E-Learning der globalen Zulassung und regulatory LEAN.

Services

• Regulatory Affairs Service in China
• International market access
• Interim manager
• Legal representative service
• Training
• Outsourced testing

🏆Workshops

• Chinese registration
• All about Chinese QMS
• International registration
• Intercultural communication
• KPI in regulatory affairs

🎓E-Learning of regulatory affairs

• Global markets
• Chinese market access
• FDA market access
• EU CE
• Taiwan market access
• MDSAP success
• Regulatory Affairs Soft Skills
• Just for start-ups

Blogs

NMPA regulation, Chinese technical documentation, PTR, Type testing, Clinical evaluation, Chinese PSUR, Chinese labelling, Essential principle of safety and performance, Chinese standard, IVD registration

FDA to NMPA, Brazil Access, Canada access, Taiwan access, ASEAN access, Vietnam access, Testing in global registration, Perfect regulatory manager

Technical documentation, Design change assessment, Global quality management, International database, International markets for Start-ups