Medical Device Assembly Services
To support the manufacturing of high-quality medical devices and critical components, our medical device assembly services include assembly, testing, and packaging of medical components in an ISO 7 cleanroom. With a tightly controlled, clean environment and ISO 13485:2016 certification, we deliver precise, compliant custom medical products for even the most complex, highly regulated applications.
Contact us to discuss your medical device assembly project, and one of our representatives will be happy to answer any questions you may have.
What are Medical Device Contract Assembly Services?
Medical device contract assembly services shift the responsibility of assembling critical medical devices to a service provider. This route offers access to specialized expertise, faster speed-to-market, and lower capital expenditure, with benefits for scaling and cost efficiency. Choosing in-house assembly can lack the specialized experience that contract manufacturers offer, potentially constraining scalability and increasing risk, with the tradeoff of internal process visibility.
Primo Medical Group can work with you on custom medical devices from concept to completion, or handle assembly services, delivering cost benefits, compliance, and efficiency for a range of medical products.
Our Medical Device Assembly Capabilities and Services
Specializing in the medical industry, Primo Medical Group offers a comprehensive range of services to support medical device manufacturing and assembly. Our medical device assembly services utilize ISO 7 cleanroom environments with manual, automated, and multi-component assembly, and kitting and packaging capabilities. Additionally, by integrating component sourcing and environmentally controlled CNC machining, we can ensure the highest levels of precision and contamination control, reducing risk, enhancing traceability, and streamlining production workflows.
Cleanroom Medical Device Assembly Quality Standards
We understand the importance of medical device assembly within a contamination-free environment. With over 47,000 sq. ft. of ISO 7 cleanroom space, our services can support cleanroom medical device assembly certified to ISO 13485:2016 and compliant with GMP in controlled environments. Our facility includes strict contamination control, inspection, and validation, ensuring environmental parameters meet product- and client-specific requirements, supported with documentation, traceability, and risk reduction practices.
Specific Applications and Devices Assembled
In addition to sourcing and manufacturing components for assemblies, we offer medical device assembly services and contract assembly to finish products to application and industry requirements. Our assembly services include finishing the following, but not limited to, applications and devices:
- Vein harvesting devices
- Laparoscopic instruments
- Neurosurgical and surgical tools
- Robotic surgery components
- Body sculpting instruments
- Endoscopic instruments and sheaths
- Electromechanical medical consoles
- Bone screws, tapered posts, and orthopedic implants
- Simple and complex catheters with braided or coiled wire, and hypotube components
Why Work with Primo Medical Group for Cleanroom Medical Device Assembly?
Primo Medical Group offers over 45 years of experience in the development, manufacturing, and assembly of critical medical products. With end-to-end support, we provide engineering and design assistance through manufacturing and fulfillment to ensure your products meet exact specifications and are supported by the necessary quality and regulatory standards for their intended use. Our expertise enables us to handle complex, high-precision medical components made to your exact project requirements.
Contact Us for Contract Assembly Services for Medical Devices and Components
As a full-service contract manufacturer, we have decades of experience serving the medical, aerospace, and defense industries. Our FDA-registered facility supports cleanroom manufacturing and assembly services with over 47,000 sq. ft. of cleanroom space meeting ISO 7 or Class 10,000 standards for controlled production environments, ensuring contamination control and quality for your projects. We can work with you from concept to completion, focusing on assisting with complex or highly regulated projects that require strict compliance. Contact Primo Medical Group or request a quote to begin.