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Medical Plastic Injection Molding

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Medical Device Assembly

Seaskymedical, a professional medical assembly company, is capable of assembling medical device in Class 8 Clean Room, which guarantees the sterilisation of medical device and provides added security.

10+ Years Specializd in Clean Room
Medical Device Assembly

The development in the healthcare industry has led to the manufacturing of medical devices that needs to be assembled together. Assembling these devices could be time-consuming and labor-intensive. Not only that, it has to be done in a clean and contamination-free environment, so finding reliable medical device assembly companies is necessary. As a medical molding manufacturer with over 10 years experience in clean room medical device assembly, we carry out this function effectively. We comply with product and regulatory requirements that ensure that medical devices are rightly assembled and safe for use. Also, we perform this function in our Class 7 & 8 Clean room that’s void of any contamination and pollutant, thereby ensuring that the medical devices remain clean and hygienic.
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Our Medical Equipment Assembly Services:

  • Ultrasonic and spot welding
  • Heat staking
  • Surface treatment
  • Bonding
  • Crimping
  • Kit packaging
  • Functional testing
Medical device assembly in clean room

Medical Device Assembly & Kitting

We offer medical device assembly and kitting services that are suited to your exact specifications. Asides from benefiting from our assembly and kitting services, we can also help you manage your supply chain and sourcing needs. Below are our basic services.

  • Dedicated clean room
  • Sterilization consultation
  • Short delivery time
  • Assembly expertise
  • Quality controls
  • ISO 13485:2016
  • Manufacturing of Class II and Class III devices

Assembly & Process Capabilities

Seaskymedical has the expertise needed for medical device contract assembly. We enjoy the challenge of implementing new technology and are always expanding our processes and capabilities to suit the demands of our customers. Below are some of our capabilities.

  • In-house EO sterilization
  • Ultrasonic, UV/adhesive bonding
  • Automated tube cutting and cooling
  • Functional testing
  • Pad and screen printing
  • Laser making

Assemblies Process from Top Medical Device Assembly Companies

As one of the top medical device assembly companies, we carry out several processes in assembling customers’ medical services. Our Class 8 clean room is available for the manufacturing and assembly of medical devices that require sterilization of lower bioburdens. Below are the key features of our medical equipment assembly services.

  • Manufacturing pilot lines are used to test, analyze, certify compliance and finalize for production.
  • Processing of Failure Mode and Effect Analysis (FMEA).
  • In ISO Class 7 and 8 environments, medical devices are assembled in clean rooms.
  • From sub-assembly to delivery, sterile devices, epoxy UV curing assembly, mechanical assembly, part touching and sealing, and tray sealing are all performed.
  • Tensile, compression, and torque testing, as well as pressure decay and flow rate leak testing, are all part of the verification and validation process.

Why Seaskymedical
for Medical Device Assembly

We are a trusted and reliable company that has been carrying out medical device assembly and medical device packaging for over ten years. Using medical device assembly machines guarantees our professionalism and experience, and the benefits you stand to gain. Below are some of the reasons why you should choose Seaskymedical for your medical devices assembly.

ISO 13485:2016

Amongst our several qualifications that you will benefit from is a quality management system that prioritizes meeting customers and applicable regulatory requirements. Professional medical device assembly companies must equip with ISO 13485:2016 certificate, which could guarantee the safety of your medical devices.

Assembly Class I, II, III medical devices

You will get the service of experts who are proficient in handling medical devices in the three assembly classes i.e., Class I (low-risk devices), Class II (moderate-risk devices), and Class III (high-risk devices). So, no matter the risk involved, you will be rest assured that there will be no flaw.

Class 7 & 8 clean room medical assemblies

The assembling of your medical products will be carried out in a 3,600 square meters clean room dedicated to plastics used in medical devices. This ensures cleanliness from all through.

Expertise in sterile barrier packaging (ISO 11607)

Your medical devices will be well-packaged to withstand sterilization processes and remain protected until the moment they are needed.

One stop service and scalability

We have everything you need, so you can trust us to handle all your medical device assembly needs, as well as medical contract manufacturing. There are sufficient resources (human and technology) to handle all your assembly needs, whether high-volume or low-volume.

Cooperate with the best machine manufacturer in the world

We are a medical molding company, proficient in several areas, such as overmolding injection molding and cnc molding, and some other value addition process. We also incorporate robust quality control in our manufacturing processes, thereby ensuring no flaw in your projects.

Custom machinery

You will be provided with machinery fabrication services. We work with the best equipment fabrication companies in the world to ensure that your machineries are customized to your exact preference.

Low cost

With the help of medical device assembly automation, you don’t have to empty your bank. Our medical device assembly service is affordable. Also, we help to reduce your future costs by optimizing your medical devices to offer higher outputs.

Frequently Asked Questions About Medical Device Assembly

SeaskyMedical provides medical device assembly services including ultrasonic and spot welding, heat staking, bonding, crimping, kitting, and functional testing. The appropriate assembly process depends on the component materials, joint design, device configuration, production requirements, and the specifications defined for the project.

Yes. SeaskyMedical provides medical device assembly in Class 7 and Class 8 cleanroom environments for projects with defined cleanliness and contamination-control requirements. The appropriate assembly environment depends on the device, components, manufacturing process, packaging requirements, and customer specifications.

Available joining methods include ultrasonic welding, spot welding, heat staking, UV or adhesive bonding, and mechanical assembly. The appropriate method depends on factors such as the materials being joined, component geometry, required joint performance, production volume, and intended function of the assembled product.

Yes. SeaskyMedical can combine assembly and kitting according to the required product configuration. Components can be organized and assembled according to project specifications, while related kitting requirements can be incorporated into the manufacturing workflow to simplify downstream handling and supply coordination.

Testing requirements are defined according to the device and assembly process. Depending on the project, evaluation may include functional testing and mechanical or integrity-related tests such as tensile, compression, torque, pressure decay, or flow-rate leak testing. The required methods and acceptance criteria should be established for the specific product.

SeaskyMedical can evaluate assembly projects for different production volumes. The appropriate manufacturing approach depends on part complexity, assembly steps, required testing, production quantity, and opportunities for automation. Higher-volume projects may benefit from dedicated fixtures or automated processes, while lower-volume projects may require a more flexible assembly setup.

Provide drawings or 3D CAD files for the components, a bill of materials when available, expected production volume, assembly sequence or specifications, and any required joining or testing processes. You should also identify cleanroom, kitting, packaging, quality, inspection, and other project-specific requirements.

Talk to Our Experts Now

    Try Our Problem-solving Injection Molding Services Now

    Seasky Medical serves you with medical injection molding solutions from design to tooling to material selection and manufacturing. Contact our specialized team and solve your problem now.

    • ISO 8 Cleanroom
    • Robust Expertise for Medical Injection Molding
    • Advanced Injection Molding Machines
    • Quick Response within 12 hours

    Try Our Problem-solving Injection Molding Services Now

    Seasky Medical serves you with medical injection molding solutions from design to tooling to material selection and manufacturing. Contact our specialized team and solve your problem now.

    • ISO 8 Cleanroom
    • Robust Expertise for Medical Injection Molding
    • Advanced Injection Molding Machines
    • Quick Response within 12 hours

    Talk to Our Experts Now

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        • 1st Floor, Building A2, Fumin Industrial Park, No. 13 Hesha Road, Fuhai Street, Baoan District, Shenzhen City, Guangdong Province, China
        • +86 18926038944
        • sales@seaskymedical.com
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