Quality & Regulatory
Quality & Regulatory
Our commitment to quality is not a compliance exercise — it is the foundation of everything we manufacture. Every instrument that leaves our facility meets the highest standards of safety, performance, and regulatory compliance.
Our Commitment
A Quality System Built for Medical Devices
Eagle Surgical works exclusively with manufacturers who hold ISO 13485:2016 certification covering the design, development, manufacture, and supply of orthopaedic surgical instruments and medical devices. This framework drives continuous improvement across every stage of our supply chain — from raw material through to final product release.
Certifications & Registrations
Regulatory Compliance
Eagle Surgical works with manufacturers who hold ISO 13485:2016 certification — the international standard for medical device manufacturers. This certification covers design, development, production, installation, and servicing of medical devices.
Eagle Surgical products are supplied through TGA-registered manufacturers listed on the Australian Register of Therapeutic Goods (ARTG), ensuring full compliance with the Therapeutic Goods Act 1989 and associated regulations.
Selected Eagle Surgical products are sourced from manufacturers holding CE marking in accordance with the EU Medical Device Regulation (EU MDR 2017/745), demonstrating conformity with European safety, health, and environmental protection requirements.
Our manufacturing partners maintain technical documentation and clinical evaluation processes aligned with EU MDR 2017/745, ensuring products meet the rigorous standards required for the European medical device market.
Quality System
Eight Pillars of Quality
Design Controls
Structured design and development controls ensure every new instrument is designed, verified, and validated in accordance with ISO 13485 requirements. Design history files are maintained for all products.
Risk Management
Comprehensive risk management in accordance with ISO 14971 is applied throughout the product lifecycle — from design inputs through post-market surveillance — to identify, evaluate, and control risks to patients and users.
Supplier Controls
All critical suppliers are qualified, monitored, and re-evaluated on a regular basis. Incoming material inspection and supplier audits ensure raw materials and components meet our exacting specifications.
In-Process Inspection
Rigorous in-process inspection at defined manufacturing stages ensures non-conformances are detected and addressed before they progress. Statistical process control is applied to critical manufacturing parameters.
Final Inspection & Release
Every product undergoes final inspection against approved acceptance criteria before release. Certificate of conformance documentation is provided with all shipments.
Post-Market Surveillance
Our post-market surveillance system monitors product performance in the field, captures customer feedback, and drives continuous improvement. Vigilance reporting obligations are met in all markets where our products are sold.
CAPA & Continuous Improvement
A robust corrective and preventive action (CAPA) system ensures that non-conformances, complaints, and audit findings are systematically investigated, resolved, and prevented from recurring.
Traceability
Full lot traceability is maintained for all products from raw material through to the end customer. Unique device identification (UDI) labelling is applied in accordance with applicable regulatory requirements.
Applicable Standards
Standards We Work To
Our products and quality system are designed and maintained in accordance with the following international and national standards and regulatory frameworks.
Quality Documentation Available on Request
ISO 13485 certificates, TGA registration details, CE marking declarations, and certificates of conformance from our manufacturing partners are available to qualified customers and regulatory bodies upon request.