Regulatory affairs in Japan

Strategies for regulatory affairs
QMS establishment, operation and maintenance
Design development and technical documents
Product approval applications
Post-marketing regulatory affairs
National Health Insurance (NHI) coverage
Fixed-term contracts

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Acquisition of CE marking

CE marking requirements
Transition to the Medical Devices Regulation (MDR)
Clinical evaluations
Technical files and design dossiers
EN ISO 13485-compliant QMS
Consulting services related to selecting a European Authorized Representative
Post-marketing safety management activities
Benefits of CE marking in ASEAN countries
Medical Device Regulation (MDR)

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US Market Entry

Support for examining US application strategies
Compliance with QSR or QMSR
Preparation of application forms and support for standards compliance

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Entry into the medical device market

Overview of entry into the medical device market
QMS and GVP systems
Business licensing, registration and notification
Product approval/notification applications

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Compliance with standards during design development

Design development and technical documents
Key medical device standards
Japanese and overseas requirements

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Acquisition of ISO 13485 certification

ISO 13485 requirements
Strategic decisions
Client compliance with requirements
QMS development and documents
QMS operation

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Acquisition of MDSAP Certification

MDSAP requirements
Strategic decisions
Gap analysis
MDSAP development and documents

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