eQMS

Integrated quality management with 16 modules for pre- and post-market regulatory compliance, deployable in 5 days.

Overview

MyBlueLabel eQMS is an electronic Quality Management System designed to support life sciences and medical device companies across all stages of their regulatory journey. The platform consolidates 16 modules into a single integrated solution, with individual modules enabled according to each company's specific compliance needs. MyBlueLabel states the system can be established within five days.

The platform addresses both pre-market and post-market compliance requirements, covering a range of regulatory frameworks including FDA regulations, EU MDR, CE-mark, ISO 13485, ISO 9001, ISO 14001, and ISO 27001.

Pre-Market Capabilities

Regulatory approval support
ISO certification management
Audit management
Clinical trial preparation
Supplier management
Risk management

Post-Market Capabilities

Document management
Comprehensive annual reviews
Incident management
Post-market surveillance
Complaint handling
Risk management

Regulatory Standards Supported

FDA regulations
EU MDR (Medical Device Regulation)
CE-mark
ISO 13485
ISO 9001
ISO 14001
ISO 27001

The platform is structured as a modular system, allowing companies to activate only the modules relevant to their regulatory obligations. This approach is intended to support organisations at different stages of compliance maturity, from initial regulatory approval through to ongoing post-market obligations.