ISO 13485: Simplified Compliance for Medical Device Excellence

This section outlines the general requirements for establishing, documenting, implementing, and maintaining a QMS that complies with ISO 13485.

• Document Management
• Change Management
• Audit Management
• Training Management
• NC Management
• CAPA Management
• Complaints Management
• Supplier Quality Management

This section focuses on the responsibilities of top management, including their commitment to the QMS, establishment of a quality policy, and communication of quality objectives.

• Document Management
• Change Management
• Audit Management
• Training Management
• Dashboards & Reports

It covers the allocation of resources, including human resources, infrastructure, and work environments, to support the QMS effectively.

• Document Management
• Change Management
• Training Management

This section delves into the processes related to product development, design, and manufacturing, emphasizing the need for risk management and validation activities.

• Document Management
• Change Management
• Risk Management

This section details the requirements for monitoring and measuring processes and products, conducting analysis, and implementing corrective and preventive actions to enhance the QMS continuously.

• Document Management
• Change Management
• NC Management
• CAPA Management
• Complaints Management
• Training Management
• Change Management
• Dashboard & Reports