Training services including:

• Prepare for ISO-13485 QMSR Compliance
• Software Development for Medical Devices
• Safety and Security Risk Management



Consulting services to help your organization:



• Develop a compliant and cost-effective Quality Management System
• Create SOPs based on Regulations, Guidance Documents and Standards
• Comply with IEC-62304 Software Development Lifecycle
• Comply with ISO-14971 Safety Risk Management
• Comply with ANSI/AAMI SW96 Security Risk Management
• Comply with ISO-13485 Quality Management Systems
• Comply with IEC-62366-1 Usability Engineering



Auditing services to help:



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