top of page
HOME
Service
International market access
Chinese market access
Interim manager
Legal representative service
Testing service
Compliance Template
Academy (eLearning)
Example of E-Learning
International market access
US FDA
Use FDA clearance globally
510k exempted in US
FDA & NMPA
China
Registration of medical device
Registration of IVD in China
Chinese distributor versus Chinese agent
Change in Chinese registration
Device description
Clinical evaluation
PTR and type testing
Chinese labelling
EU MDR
MDR impact
TD sampling in EU
DOC at Global Markt
Eudamed
Taiwan
Market access in Taiwan
Quality System Documentation
Taiwan distributor
Learning from US and Chinese authority
Legal representative
Brazil and MDSAP
Market access in Canada
Market access in Vietnam
Market access in Indonesia
International vigilance
Global landscape
Classification of medical device
Navigating database of medical device
Influence product certificate
Medical Device Grouping
Equivalent Medical Devices
Innovative products
Global acceptance of foreign certificate
Global acceptance of quality management
Obsolete product
Regulatory Intelligence
Swith of stakeholders
Translation in regulatory work
Soft skills of RA manager
Risk management as submitter
Communication skills
Subcontractor
Test of regulatory intelligence
Insights
Technical documentation
Technical documentation
Change registration
Licence amendment in Canada
Testing in V&V
Medical material
Quality Management
Global quality management
QMSR
Medical supplier
Change assessment
Change assessment
Change in technical documentation
Change decision tree in Singapore
Labelling
International labelling
Labelling in Taiwan
Korean Labelling
UDI
bottom of page