From complex PCB assemblies to fully integrated electronic systems, August Electronics provides ISO 13485-certified, advanced manufacturing for medical device companies. We support medical electronics from NPI and early production through ongoing manufacturing, with the process control, full traceability, testing, and quality systems required for highly regulated products.
Medical electronics cover a wide range of applications, and patient care outcomes and treatment costs both depend on that hardware performing exactly as specified. Meeting the regulatory standards and regulations that govern it requires a medical electronics manufacturing partner with quality control that does not move.
At August Electronics, we’re an electronics manufacturing partner to medical device OEMs. Our team builds populated boards, wire harnesses, control panels, and fully integrated units, then rigorously tests and ships them. You manage one relationship rather than coordinating a board shop, a harness supplier, and an integrator.
Our procurement team sources electronic components through established supplier relationships, which helps manage cost, availability, and supply chain security. Every part is logged against your bill of materials (BOM) and tracked through assembly, supporting component traceability and helping catch and address problems tied to product quality, counterfeit parts, or assembly errors before they ship.
August Electronics’ manufacturing operations are supported by ISO 9001:2015 and ISO 13485:2016 certified quality management systems, with our medical manufacturing capabilities focused on electronics for non-implantable medical devices. Assemblies can be built to IPC-A-610 Class 2 or Class 3, depending on the reliability your application requires.
OUR CAPABILITIES
We build populated boards for medical applications using surface-mount, through-hole, and mixed-placement technologies, assembled to IPC-A-610 Class 2 or 3 as your specification requires. Every board is barcoded and tracked through each stage of assembly. See our full PCB assembly capabilities for equipment and file requirements.
Medical electronics assembly rarely ends at the board. We install and configure PCBAs into the larger system, build the mechanical and electromechanical sub-assemblies around them, including control panels, and integrate the wiring and cable systems that tie everything together. Packaging, labeling, and delivery logistics are handled here as well, so the finished device is built, tested, packaged, and prepared for shipment to your requirements.
Automated wire preparation and crimping equipment produce discrete multi-conductor cables and wiring harnesses for medical equipment, including specialty cables built to your drawings and specifications. Each harness is electrically verified before it is included in a build. We manufacture cable assemblies as standalone orders or as part of a full integration.
The right combination of tests depends on your device: functional and performance testing to confirm it operates as specified, dielectric testing to verify electrical integrity, and fault identification to isolate potential failure points in medical device circuits. Our testing and inspection process is built around your requirements.
MANUFACTURING PROCESS
We start by aligning on what your device does, where it operates, and the manufacturing, quality, testing, and regulatory requirements that apply. This early collaboration tells us what the build has to deliver and what needs to be controlled during production.
You share your documentation, including Gerbers, ODB++ files, BOMs, test procedures, and mechanical specifications. Our team reviews it for manufacturability, risk factors, and alignment with the regulatory requirements already established for your device.
Together, we set volumes, timelines, testing expectations, and any longer-term needs such as refurbishment support. These details shape the quote, and scope often continues to be refined as quoting moves forward.
You receive a detailed estimate covering materials, labor, lead times, and any NRE costs, along with the assumptions behind them. That gives you visibility into cost and the factors that can affect delivery, ahead of production.
Once approved, a dedicated project manager becomes your primary point of contact, connecting you to procurement, production, quality, and planning. If something changes, like a supply chain delay, you hear about the impact and next steps directly from them.
Before moving into production, we complete process validation and review the pilot together against your technical and business objectives. That review shapes the plan from there, whether that means scaling up, another iteration, or staying at the volume you're already running.
After launch, we support the products we manufacture through repair and refurbishment. That's lifecycle support, keeping your device in service longer as demand shifts.
TESTIMONIALS
WHY AUGUST ELECTRONICS
Our quality management system is ISO 9001:2015 and ISO 13485:2016 certified, with our medical manufacturing capabilities focused on electronics for non-implantable medical devices. Assemblies can also be built to IPC-A-610 Class 2 or 3, depending on your specification.
Each assembly is barcoded and tracked through every manufacturing stage, with components logged and verified against your BOM. Non-conformances and defects are tracked and closed out inside our quality system, so the documentation behind your device holds up to scrutiny.
We specialize in low-to-mid-volume, high-mix production with no fixed minimum order quantity. That model supports evolving demand, product revisions, multiple configurations, and changing production requirements without requiring the economics of mass production.
Our rigorous testing strategies eliminate risks and ensure your product's reliability. Every communication system undergoes dielectric testing, functional testing, and AQL inspections to verify safety and functionality.
RESOURCE LIBRARY
CONTACT US
The core requirement is a BOM and Gerber files covering all layers of the board. Supporting files speed things up, including a pick and place or centroid file, assembly drawings with reference designators and quantities, fabrication drawings, panelization files, and stack-up details.
For medical device electronics assembly, we also need your test procedures and mechanical specifications, since testing criteria and enclosure requirements are defined on your side. Where documentation is incomplete, our engineering team works with you to validate the data before assembly begins.
Our facility is in Calgary, Alberta, and we ship across North America and internationally. Packaging, labeling, and delivery are managed by our outbound logistics team, with ESD-protected packaging options and customs documentation prepared for cross-border shipments. Drop shipping directly to your customers or end users is available, along with partial shipments across multiple destinations when your delivery schedule calls for it.
Repair and refurbishment covers cleaning, upgrades, damage repair, and retesting, and extends to products built more than 15 years ago.
For medical device manufacturing programs where equipment stays in service for a decade or longer, this keeps your installed base supported well past the original production run.
August Electronics specializes in low-to-mid volume, high-mix production, with no fixed minimum order quantity. That suits medical OEMs who need quality-focused medical electronics manufacturing without the order minimums that high-volume manufacturers impose. We handle prototype builds, pilot runs, and full production, and can scale between them as your device moves through approval and into the field.
Yes. We are a trusted partner in the medical industry, no matter your size. This includes early-stage startups introducing a first product and established OEMs running mature, high-mix production. We’ve supported OEM programs across a range of device complexity: single-board products built around basic sensors, and complex, multi-board systems such as magnetic resonance imaging (MRI) sub-assemblies. The manufacturing and quality processes stay the same either way.
Regulatory compliance is a priority at August Electronics, which is why our quality management system is certified to ISO 9001:2015 and ISO 13485:2016, with our medical manufacturing capabilities focused on electronics for non-implantable medical devices. Medical device electronics are assembled to IPC-A-610 Class 2 or 3, depending on your specification, by a team certified to that standard for electronic assemblies. Our facility also meets CSA, UL, and ETL safety standards.