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Strategic planning for global market access

PredicatedEquivelent / Predicated device survey

Contract service of scientific research

Transformation of scientific research results

Quality System Consulting

Risk Management

Medical Device Software Validation

Process Design and Development / Design tranfer

Design Verification / Validation Planning

Biological Evaluation

Preclinical Animal Study

Reprocessing Validation

Product Performance Testing Registration Testing

Human Factor / Usability Evaluation

Microbiological Tests

Cybersecurity Test

Package Verification and Shelf Life Verification

Electrical Safety Testing

Clinical Evaluation

Regulations and Standards Training

Application of Medical Device NMPA Registration

U.S. Premarket Notification [510(k)] Submission

U.S. PMA / De Novo Classification

CE Marking and UKCA consulting

Russia and CIS Registration Consulting

Canada Medical Device License Application

Brazil ANVISA Registration

Quality System Inspection Support

Local representative service

Post-market clinical follow-up

Adverse event handling

Regulatory research and product change planning

Registration / certification changes

Product market withdraw services

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