Together, Advancing Patient Outcomes

Finished Device Assembly and Packaging

Finished Medical Devices for MedTech and Pharma Customers

Cadence assembles Class I and Class II registered devices for some of the most demanding customers in the MedTech and Pharma markets in our eGMP facilities, including dedicated device facilities in Cranberry Township, PA, and Alajuela, Costa Rica.

Cadence prides itself on a strong track record of regulatory compliance. All our facilities are ISO 13485 certified and registered with the FDA where applicable. Our robust Quality Management System (QMS) ensures compliance with all regulatory requirements and standards.

We provide the following finished device capabilities:

  • Cleanroom Manufacturing (Class 7 and Class 8)
  • Final Assembly
  • Testing and Inspection Services
  • Final Packaging and Labeling
  • Sterilization Management
  • Supply Chain Management

Final Assembly of Medical Devices

Caprecise processes to ensure the proper function of the device while meeting regulatory requirements. These products often get assembled, packaged, labeled, sterilized, and are shipped directly to our customers’ manufacturing and distribution facilities. The integrity of the device is paramount as it impacts patient safety and is a critical step in the medical device life cycle.

Cadence operates two dedicated finished device assembly facilities in Cranberry Township, PA and Alajuela, Costa Rica. Both facilities maintain ISO Class 7 cleanrooms, are ISO 13485 certified, and assemble, package and ship Class I and Class II FDA registered products. We partner with our customers through the many stages of the product life cycle from engineering and operations support during the pre-clinical phases, to new production introduction, through product transfers to improve supply-base scalability or to take advantage of nearshore costs. Our experienced engineering, quality, supply-chain and operations teams are ready to help across the many stages of your product development process.

Some of our medical device qualifications include:

  • Class 7 Certified Cleanroom
  • Class 8 Certified Cleanroom
  • Cleanroom Injection and Insert Molding
  • cGMP / CFR 21 Part 820 Compliant
  • FDA Registered Products/Facilities
  • ISO 13485:2016 certified

Final Packaging & Labeling for Medical Devices

Packaging and labeling of finished devices are a critical step in assuring that products get to the market properly. Cadence specializes in packaging and labeling sterile and non-sterile medical device assemblies. We have extensive medical device expertise in FDA 21 CFR 820 and ISO 13485.

Our packaging expertise lies in design support, development and validation of custom packaging of precision components, sub-assemblies and finished medical devices including related processes in compliance with the appropriate regulatory standards. This includes understanding complex needs for pouching, labeling, sealing, shrink-wrapping, and boxing.

Cadence’s expertise in “sharps” translates directly to the handling throughout the entire manufacturing process, including through semi-automated and fully automated assembly solicitors. Our engineering team provides support through the entire development process to minimize damage to highly engineered precision products.

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