Consultancy services in the areas of:
 - Medical Device Regulatory Affairs
 - In Vitro Diagnostic Regulatory Affairs
 - Quality Management (ISO 13485:2016)
 - Risk Management (ISO 14971:2019)
 - EU, UK, US, APAC, LATAM device registrations
 - Clinical Affairs
 - Technical Documentation
 - Regulatory Strategy
 - Device Classification
 - Clinical Evaluation Plan/Report
 - Performance Evaluation Plan/Report
 - State of the Art Plan/Report
 - Analytical Performance Plan/Report
 - Clinical Performance Plan/Report
 - Scientific Validity Plan/Report
 - Biological Evaluation Plan/Report

Call or message for more information on services and to arrange a friendly call to discuss the specific needs of your business

Health Services

Consulting

BaxMed Regulatory Ltd

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