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Workshop and training
Workshop: intercultural communication
Workshop: reproduce success
Workshop: KPI in regulatory affairs
Workshop: for international markets
Service
Chinese market access
International market access
Legal representative service
Interim manager
Testing service
Compliance Template
Academy (eLearning)
Example of E-Learning
International
China
Chinese distributor versus Chinese agent
Registration of medical device
Registration of IVD in China
Change in Chinese registration
Device description
Clinical evaluation
PTR and type testing
Chinese labelling
MDR impact
Lerning from US and Chinese authority
Legal representative
510k exempted in US
FDA & NMPA
Brazil and MDSAP
Market access in Taiwan
Market access in Canada
Market access in Vietnam
Market access in Indonesia
International vigilance
Market access
Classification of medical device
Navigating database of medical device
Influence product certificate
Medical Device Grouping
Equivalent Medical Devices
Global acceptance of foreign certificate
Global acceptance of quality management
Obsolete product
Insights
Technical documentation
Technical documentation
Change registration
Licence amendment in Canada
Testing in V&V
Medical material
TD sampling in EU
Quality Management
Global quality management
QMSR
Medical supplier
Change assessment
Change assessment
Change in technical documentation
Change decision tree in Singapore
Labelling
International labelling
Korean Labelling
UDI
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
!Black week 2025!
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