Australia
Australia
Hong Kong
+61 3 9875 7800 Mon - Fri 07:00AM - 5:00PM 14 Redland Dr, Mitcham, Victoria
+852 2350 0618 Mon - Fri 09:00 - 17:00 Unit 602, 34 Tai Yau Street, San Po Kong Kowloon
Certified
ISO 9001:2015
GOLD Award
2021 Bus. Excellence
Finalist
2021 Defence MFR
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Medical Electronics Manufacturing Australia

ISO 13485 Certified Solutions

Custom PCB assembly and medical device manufacturing supporting MedTech innovation and patient safety.

At Precision Electronic Technologies, we partner with Australia’s world-class and rapidly growing and evolving MedTech sector to deliver safe, compliant, and innovative medical equipment. As part of a nation recognised globally for excellence in both MedTech and biomedical innovation, our Melbourne-based team provides ISO 13485-aligned manufacturing — from PCB assembly to complete device builds — supporting the development of next-generation healthcare technology and improving outcomes for patients and providers alike.

To support scale as your device gains traction, we also offer a seamless transition to our long-standing offshore manufacturing partners, all ISO 13485 certified, ensuring continuity of quality and compliance when production volumes outgrow local capacity.

Supporting innovation across Australia's MedTech sector

At Precision Electronic Technologies, we work with leading MedTech innovators to manufacture electronics that power a wide range of healthcare technologies. From preventative care to surgical planning, our assemblies are designed for performance, safety, and compliance in critical medical environments.

We supply medical-grade assemblies and subsystems used in:

  • Ophthalmic imaging – including high-quality corneal topographers, perimeters, and HP-OCT whole-eye measurement systems
  • Cardiac and vital signs monitoring – such as heart rate monitors and portable diagnostic units
  • Hearing technologies – assisting in the function of advanced hearing implant systems
  • Infection control – including automated probe disinfection systems used in clinical settings
  • Preventative and public health – including self-service health check wellness stations for pharmacies and clinics

ISO 13485 & Medical Compliance

Aligned with Australia’s highest medical manufacturing standards

Precision Electronic Technologies is currently progressing toward ISO 13485 certification, with our formal audit scheduled for the last quarter of 2025. This milestone reflects our commitment to manufacturing medical electronics that meet the most stringent global quality and regulatory standards.

Our systems are built around:

  • Traceable processes and complete documentation for every build
  • Controlled environments and handling protocols suited to medical device assembly
  • Alignment with recognised international medical device regulations
  • A mature quality management system (QMS) grounded in ISO 9001 and expanding toward ISO 13485 compliance

We understand the importance of risk management, validation, and documentation throughout the medical device lifecycle. Our customers rely on us not just for precision manufacturing — but for the confidence that their product can move smoothly through audits, regulatory reviews, and clinical deployment.

Our commitment to quality goes beyond compliance. As a Gold Award recipient under the Australian Business Excellence Framework (ABEF), we apply business excellence principles across all aspects of our business — driving continuous improvement, customer focus, and long-term reliability in everything we deliver. This culture of excellence underpins the quality of both our products and our service.

Medical Manufacturing Services Full-service manufacturing for medical electronics and equipment

At Precision Electronic Technologies, we offer end-to-end manufacturing services for medical devices — from PCB assembly to full product builds. Our Melbourne-based facility delivers quality, traceability, and flexibility across every stage of the manufacturing process.

Our medical manufacturing capabilities include:

High-reliability PCB assembly

with in-house testing and inspection tailored to medical requirements

Precision cable assemblies

and wiring harnessesfor use in regulated healthcare environments

Complete box build and

enclosure assembly, including integration of wiring, and mechanical components

Packaging and labelling support

to assist with your documentation and regulatory needs

We partner with MedTech companies developing everything from imaging systems and diagnostic equipment to public health kiosks. Whether you need production-ready volumes or small-batch assembly for clinical trials, our team is ready to support your device build with the quality and care it demands.

Prototype to Production for Medical Devices

Supporting your product journey from concept to commercialisation

At Precision Electronic Technologies, we help MedTech innovators bring devices to life — starting with fast-turnaround prototypes and scaling through to full production.

Whether you’re refining a design for clinical trials or preparing for commercial launch, we provide manufacturing support that’s responsive, reliable, and aligned with regulatory expectations. Our ISO 13485-aligned processes ensure each stage is executed with quality, traceability, and patient safety in mind.

We offer:

  • Rapid prototype builds for functional testing, validation, and investor/demo use
  • Engineering feedback to support manufacturability and compliance readiness
  • Scalable production pathways with consistent quality control from first article to full run

Our flexible model means you can start locally with a trusted Australian team and scale globally when needed. Through our ISO 13485-certified offshore partners — with whom we’ve built long-term relationships — we can support the full product lifecycle, from early-stage builds to high-volume production, without compromising on quality, traceability, or compliance.

Close up of Silver and Gold Award

Medical Client Testimonials

Trusted by MedTech innovators across Australia

Clients trust us not only for our medical manufacturing expertise, but also for our proven commitment to business excellence. As a Gold Award winner under the Australian Business Excellence Framework (ABEF), we apply its principles to ensure high standards of leadership, systems thinking, and customer-focused improvement — all of which directly contribute to the quality of our output and reliability as a partner.

  • Precision helped us get from prototype to production with minimal delays and full confidence in the build quality. Their team understood our regulatory obligations and supported us at every stage.

  • Having a local manufacturing partner who could test, document, and scale with us made all the difference. Their quality processes gave us confidence heading into compliance audits.

  • We needed a fast turnaround on a complex diagnostic system, and Precision delivered — with excellent communication and zero compromises on quality.

These testimonials reflect just a few of the ways we help our clients succeed — from diagnostics and imaging to monitoring and public health technology. We bring the same attention to detail, traceability, and service to every medical project we take on.

Frequently Asked Questions (FAQ)

What medical certifications do your manufacturing processes hold?

We are ISO 9001 certified and currently progressing toward ISO 13485 certification, with our audit scheduled for the last quarter of 2025. Our processes are already aligned with key medical manufacturing principles, including traceability, documentation, and risk management.

Can you help with small batch runs or prototypes?

Yes. We offer flexible volumes — from fast-turnaround prototype builds to small batch runs for clinical testing or product validation, all with the same level of quality oversight.

What is your typical lead time for medical assemblies?

Lead times vary depending on complexity and volume, but we work closely with clients to meet project deadlines and can often support expedited builds for urgent or early-stage projects.

What types of testing do you offer in-house?

We provide in-house testing and inspection services, including visual inspection, functional testing, and customer-specific quality protocols as required for medical device builds.

Are your manufacturing processes suitable for regulatory submissions?

Yes. Our approach to documentation, traceability, and quality control supports the regulatory requirements of medical devices. Many clients use our builds during the TGA/FDA submission or validation phase.

Start your MedTech manufacturing journey with us

Whether you’re developing a new diagnostic platform, scaling production of a monitoring device, or need a reliable local partner for assembly and testing — we’re here to help.

Our team is ready to discuss:

  • Medical device manufacturing requirements
  • Prototype or low-volume builds
  • ISO 13485 readiness and compliance support
  • Project timelines and testing expectations

Let’s talk about how we can support your next medical device project.

14 Redland Drive
Mitcham  VIC 3132
Australia