Medical Device Manufacturing
Integrated Solutions for the Medical Device Industry
At Sabre Medical, we specialise in the cleanroom assembly and manufacturing of medical devices, offering a complete, end-to-end Australian manufacturing solution. With a strong focus on quality, compliance, and scalability, we help bring your medical technology to market safely, efficiently, and in line with the stringent demands of Australian and international regulators.
Scalable Medical Device Manufacturing
All four of our purpose-built Class 7 and Class 8 cleanroom facilities are located onsite at our Lane Cove headquarters in Sydney. Designed to meet the highest standards of safety and compliance, our cleanrooms support the assembly of all classes of medical devices. From diagnostic consumables to implantable and single-use surgical products.
With both manual and semi-automated processes in place, Sabre Medical offers the flexibility to support everything from early-stage prototyping to full-scale production.
Watch our Cleanrooms in action
Arrange a tour:
Get in touch to explore our facilities and equipment including our advanced European thermoforming machine and the only Rapid Small Run Tray Forming System of its kind in the Asia-Pacific.
Trusted Team, Proven Expertise
Our multidisciplinary team includes engineers, designers, QA professionals, and logistics experts, all with deep expertise in medical device assembly, packaging, and regulatory compliance. Every process is designed to meet Therapeutic Goods Administration (TGA) and international requirements, ensuring your product is compliant from day one.
Whether you’re navigating market entry or scaling production, Sabre Medical is ready to grow with you.
Seamless Medical Device Manufacturing – All Under One Roof
Sabre Medical brings together the critical components of device manufacturing — cleanroom assembly, custom thermoform packaging, ISO 13485 compliant validation testing, and logistics — into a single, integrated solution.
Our services include:
- Cleanroom assembly (sterile and non-sterile devices)
- Medical Device manufacturing and functional testing
- Packaging design, manufacturing and validation
- Gamma and EtO Sterilisation Validation
- 3PL logistics across Australia and New Zealand
- Regulatory documentation and quality system support
- Supply of cleanroom consumables and packaging machinery
By managing multiple stages in-house, we reduce handovers, streamline your supply chain, and accelerate your path to commercialisation.
Design, Validation & Regulatory Support
Whether you’re developing a new device or scaling an existing one, our team works closely with yours to create validated, compliant processes. We support technical documentation and regulatory file preparation to meet Australian and international requirements.
Our Medical Device process development capabilities
Our capabilities encompass comprehensive support from early-stage process definition through to validated commercial manufacturing. Some of the key characteristics of Sabre’s medical device process and product development is:
- Process mapping and characterisation
- Identification of critical process parameters
- Development of robust control strategies
- Comprehensive risk assessments (per ISO 14971)
- Creation of supporting documentation for regulatory submissions
- Execution of full validation activities (IQ, OQ, PQ)
- Design transfer, managed through structured plans to ensure reproducibility and compliance across manufacturing sites
All processes are developed with scalability, traceability and regulatory alignment to ensure long-term process stability. Ensuring safe, reliable outcomes for clinicians and patients.
A Proven Partner for MedTech Innovators
Sabre Medical partners with startups, SMEs, and global manufacturers to bring high-quality medical technologies to market. We understand the complexity, urgency, and precision required to succeed in this space and we deliver.
We manufacture and assemble a wide range of medical devices and technologies including:
- Diagnostic and surgical consumables
- Class II and III implantable orthopaedic devices
- Surgical navigation and guidance systems
- Neural implants and stimulation devices
- IVF and fertility technologies
- Cleaning agents and fluid management solutions
- Custom trays and sterile barrier systems
- Medical device components and accessories
- Consumables for laboratory and diagnostic equipment
Expert Medical Device Manufacturing and Assembly
At Sabre Medical, we don’t just manufacture, we collaborate. Our team acts as an extension of yours, delivering compliant, scalable, and cost-effective manufacturing tailored to the Australian and New Zealand MedTech sectors.
From innovation to commercialisation, we bring the infrastructure, expertise, and commitment to quality that critical care and medical technologies demand.
Let’s build something life changing
Talk to us about your device, technology, or what you’re working to bring to market.