The development and marketing of medical products is a highly regulated process as per governmental regulatory requirements. Over 20 years, the BioQuality ™ team has provided development, Testing, Verification & Validation (V&V), Risk Analysis, Regulatory and Quality Assurance services to help medical devices product manufacturers meet those requirements.

>  Download PDF Version of BioQuality ™ Medical Device Services

The core areas of focus are -

• Product Development
  
• System Integration
  
• Quality System Regulations (QSR)
  
• Regulatory Compliance
  
• Risk Management
  
• Testing, QA, Verification & Validation
  
• Compliance Training
  
• Audits & Inspections
  
• Business Process Improvements