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Medical Device Manufacturing and PCB Assembly

Syscom Tech is a U.S.-based manufacturer of printed circuit boards (PCBs), electromechanical devices, and cable assemblies. Our newly upgraded platform uses cutting-edge technology to provide turn-key solutions and add-on services to our customers. Our independent, fully automated assembly lines produce top-quality products at significantly lower prices than our competitors.

Quality control is Syscom Tech’s top priority. Every step of our manufacturing process undergoes rigorous testing and is fully documented.  When you work with us, you can rest assured that affordability will never come at the expense of quality. We have completed projects for customers in an expansive range of industries, supporting the exponential growth of the medical and healthcare technology fields, as well as aerospace, automotive, avionics, and security.

medica device printed circuit board PCB assembly

​Printed Circuit Board Assembly for Medical Devices

Traditionally, a circuit board is a collection of circuits physically attached to a flat base. Printed circuit boards instead rely on techniques such as laser processing, chemical etching, and milling to cut—or “print”—the circuits directly into the base.

Syscom Tech specializes in start-to-finish PCB assembly, handling everything from design to assembly to delivery. We use state-of-the-art equipment and strict quality control processes to produce PCBs that range from simple to complex, in quantities that can be as low as a single prototype or as large as a high-volume production run.

PCBs are critical in the healthcare and medical industries, where research, diagnosis, and treatment are all increasingly automated. PCBs can be found in everything from heart monitors to pacemakers to MRIs and other medical imaging equipment.

Like all medical device components, PCBs used in medical devices are strictly regulated by the FDA’s Center for Devices and Radiological Health (CDRH). Medical device PCB assembly requirements include:

  • Establishment registration
  • Device listing
  • Premarket approval or notification
  • Investigational device exemption
  • Quality system regulation
  • Labeling requirements
  • Device reporting

custom cable assemblies medical devices

​Cable Assemblies for Medical Device Manufacturing

Customized cable assemblies bundle wires or cables together while addressing various design challenges. For example, a cable assembly might use vinyl, rubber, or thermoplastics to create a durable product that protects cables from moisture, heat, or corrosive chemicals. Custom cable assemblies are flexible and precise, and you can order them in the exact quantities needed.

Syscom Tech understands that making cable assemblies takes experience, ingenuity, and unflagging attention to details. We use cutting-edge automation techniques to produce high-performing, competitively priced assemblies that have short lead times.

As medical devices become smaller, medical device cable assemblies need to be smaller as well. The conductor, insulation, and cable jacket all affect the cable assembly’s size. When designing an assembly, the following factors must be considered:

  • Design of the conductor.Variables to consider here include the conductor’s composition and flexibility, as well as the average wire gauge (AWG), any plating or coatings, and whether the conductor is solid or stranded.
  • Insulator shields. Insulation materials must be flexible, durable, and biocompatible with the medical device, while also hindering electrical current leakage that could harm device users.
  • Cable jacket considerations.The cable jacket protects, supports, and fully encloses the conductor and its insulation. Since the jacket is located on the outside of the cable assembly, it must be resistant to environmental stresses such as heat, cold, and chemicals. For the device user’s safety, it too must resist electrical leakage.

medical device manufacturing services

Medical Device Manufacturing from Syscom Tech

In the medical industry, more than just your reputation is on the line when releasing new products—the health and welfare of patients depend on your products’ reliability and performance. From start to finish, Syscom Tech delivers complete production reliability with comprehensive testing, prototype fabrication, documentation management, and automated optical inspection. Our engineers are well-experienced in designing functional testing systems to simulate the functionality and life-saving reliability of prototype and product designs.

Syscom Tech is fully capable of developing and assembling transformative monitoring equipment, drug delivery products and other medical devices that meet the strict quality standards and regulatory requirements of the FDA. Additional services such as documentation traceability, environmental testing and supply chain/logistics are also offered to help ensure compliance and mitigate risk in the development process.

To find out more about what Syscom Tech can do for your applications, contact us today or request a quote. We look forward to working with you.

 

In the medical industry, more than just your reputation is on the line when releasing new products– the health and welfare of patients depend on your products’ reliability and performance. From start to finish, Syscom Tech delivers complete production reliability with comprehensive testing, prototype fabrication, documentation management and automated optical inspection. Our engineers are well-experienced in designing functional testing systems to simulate the functionality and life-saving reliability of prototype and product designs.

Syscom Tech is fully capable of developing and assembling transformative monitoring equipment, drug delivery products and other medical devices that meet the strict quality standards and regulatory requirements of the FDA. Additional services such as documentation traceability, environmental testing and supply chain logistics are also offered to help ensure compliance and de-risk the development process.

EMS Expertise in Medical Industry

— Small Consumables

— Monitoring Equipment


— Neonatal Infant Care Equipment

— Drug Delivery Technology

EMS Expertise in Medical Industry

 

Small Consumables

Monitoring Equipment

Neonatal Infant Care Equipment

Drug Delivery Technology

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