Providing a full range of consulting, training, and auditing services for the Medical Device, 
			BioTech and Pharma Industries.

Consulting services to help your organization:


    • Develop a compliant and cost-effective Quality Management System
    • Create SOPs based on Regulations, Guidance Documents and Standards
    • Understand and implement IEC-62304 Software Development Lifecycle
    • Understand and implement ISO-14971 Risk Management
    • Understand and implement ISO-13485 Quality Management Systems


    Training services including:


      • Software Development for Medical Devices
      • Software Verification and Validation
      • Risk Management for Medical Devices
      • Software Tool Validation
      • Computer System Validation


      Auditing services to help your organization:


      • Prepare for FDA and Notified Body audits
      • Assess compliance with internal SOPs
      • Assess compliance with Regulations, Guidance Documents and Standards