Medical Device PCBA Manufacturing
There is no nobler pursuit than to save, extend or preserve life. Companies and organizations committed to this effort should be lauded, along with companies that develop essential medical technologies for hospitals and physicians. Invariably, these medical marvels depend on electronics and PCBAs. In the medical field, where technological precision can save lives, choosing the right medical circuit board manufacturer is critical.
Your PCBA manufacturing partner should possess the depth of experience and expertise necessary to build your custom boards—however complex—with precision. Quality and reliability are not aspirations. Instead, they are mandatory requirements for meeting the demands of today’s advanced medical devices. Tempo Automation consistently meets these challenges with industry-leading turnkey medical PCB assembly services.
Tempo’s Custom Turnkey Medical PCB Assembly Service
Tempo’s digital thread manufacturing process leads the PCBA industry in building custom and complex boards fast and precisely. We develop symbiotic partnerships with our customers focused on delivering prototype and on-demand production PCBAs that meet the high-quality standards for your medical device development and applications. For more information on our advanced turnkey medical PCB assembly services, contact us.
FDA Class 1, 2 and 3 Level PCBA Manufacturing
Tempo Meets the Critical Standards of the Medical Devices Industry
Stringent regulations and standards govern the medical devices industry. Patient safety assurance is the prevailing guideline for all electronic medical devices—whether the devices are non-invasive, minimally invasive or invasive.
Tempo is a certified MedTech leader that meets the high bar set for electronics and PCBAs comprising today’s medical devices and equipment. As your partner, we will work to help you meet the quality management system (QMS) regulatory requirements stipulated in ISO 13485 by ensuring our board building process and data monitoring techniques meet regulatory compliance.
Additionally, our knowledge of the medical device approval process allows us to support your medical device development and ensure adherence to other standards, such as:
- FDA 21 CFR 801 and 820
- FCC Title 47
- IPC 6011
- IEC 60601 and 61010
Our white-box approach to PCBA manufacturing leverages openness and transparency to merge design and manufacturing and optimize the board building process. We apply software-based tools to keep you in the loop on the status of your boards. This digital thread extends to all development process principles and promotes quick and easy communication. If changes are necessary, our agile manufacturing process can readily adapt.
Essential Medical PCB Manufacturer
You Can Rely on Tempo to Meet Your Medical PCBA Needs
Recent events have taught us that the items and materials we count on may not always be available. This lesson holds for electronic components, as evidenced by the recent semiconductor backlog and enduring capacitor shortage. And this certainly applies to your PCBA CM, as many fab shops and assembly houses were forced to scale back or completely shut down due to the Covid-19 pandemic. By contrast, Tempo remained up and running at full capacity.
Our turnkey PCBA manufacturing and support services include preliminary component availability verification from one of our reliable vendor partners. Additionally, our expertise and experience providing turnkey PCBA manufacturing services for critical industries—such as the aerospace and medical industries—led to our San Francisco smart factory’s designation as an essential operation. You can trust that we are available to meet your board development needs irrespective of contingencies that may sideline other providers.
With our medical device PCB assembly services, you can be assured of the following:
ISO-9001, IPC-13485, IPC-600 and IPC-610 commitment to quality certifications.
Accurate quote in less than a day.
Fastest turnkey PCB manufacturing in the industry.
Rigid, rigid-flex and flex board capabilities for wearables and embedded biosystems.
Custom automated BOM verification tool.
Components sourced from the most reputable industry suppliers.
Software-driven robotics assembly.
Design testing capabilities, including Flying Probe.
Open and transparent PCB manufacturing experience.
Spire Health
"Tempo Automation has delivered high quality builds in just a few days, which gives us that precious extra time for bring-up and debugging."
Dylan Jackson, Lead Embedded Engineer
Boston Scientific
"I know that my project is in good hands with Tempo."
Mark Fields, Senior Validation Engineer
Ongoing Support Beginning with Your Medical PCB Design
In several cases, we have been able to step in and ensure that a client meets or shortens their development schedule due to our industry-leading turnaround time for board manufacturing. To receive the full benefit of our services, we recommend forging a development collaboration early so that we fully understand and incorporate your design intent throughout our processing. That way, you’ll have access to our DFM, DFA and engineering support from the start to ensure that your design parameters are optimally matched with the capabilities and tolerances of our advanced equipment. Our goal is not simply to build the highest quality board for you in the quickest time, but to become a reliable partner for all of your board-building needs. This includes applying our turnkey medical PCB assembly services, as well as aiding you in design, development, verification and production on the road to your device’s FDA approval.
