Omni Freedom serves the medical devices, diagnostics and equipment manufacturers
Medical devices, diagnostics and equipment manufacturers include companies that design, manufacture and distribute medical devices, diagnostic equipment and healthcare technologies in Australia and internationally. These businesses include manufacturers of diagnostic imaging equipment, surgical instruments, implantable devices, patient monitoring systems, laboratory equipment and digital health devices that are regulated under the Therapeutic Goods Administration framework.
Industry scope. Australia's medical devices industry includes domestic manufacturers, multinational subsidiaries, and distributors of a wide range of regulated products. The Therapeutic Goods Administration classifies medical devices according to risk level, requiring evidence of conformity, labelling and traceability. Medical devices include everything from bandages to active implantable devices, with registration through the Australian Register of Therapeutic Goods. There are approximately 57,000 registered medical devices in Australia, with imports dominating the market. The industry also supports research through the Medical Research Future Fund and has links to localised production initiatives.
Regulatory requirements. Medical device manufacturers must meet the Essential Principles for safety and performance, demonstrate conformity to applicable standards, establish a quality management system and maintain evidence of clinical evaluation. The TGA operates a risk-based approach, with higher-risk devices requiring more extensive evidence. Manufacturers must also comply with post-market surveillance requirements, report adverse events and maintain device traceability.
ERP needs. Medical device manufacturers need enterprise resource planning systems that support product lifecycle management, design change control, serial and batch traceability, quality management, regulatory compliance and field service management. ERP systems must support TGA compliance, manage design dossiers, track device history records, support post-market surveillance and enable recall management.
Manage product development from concept through design transfer, supporting design history files, design change control and design verification traceability for TGA compliance.
Track devices by unique device identification, lot or batch, from component receipt through manufacturing, distribution, implantation and service to support recall and adverse event management.
Implement ISO 13485-aligned quality processes, including CAPA, non-conformance, supplier qualification, internal audit and management review, integrated with manufacturing operations.
Maintain technical files, demonstrate Essential Principles compliance, manage labelling, support Australian Register of Therapeutic Goods registration and maintain clinical evaluation evidence.
Manage device installation, maintenance, calibration, repair and field service scheduling with integrated inventory, service history and customer support.
Collect, analyse and report adverse events, manage complaints, support trend analysis and maintain vigilance reporting for TGA and international regulators.
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