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