Skip to main content Scroll Top

Finished Devices & Complex Microassembly

Page/Post Excerpt
End-to-end capabilities, from pellet to finished device
With our vertically integrated structure, we partner with you from start to finish, from design and material selection to manufacturing and beyond. Our finished device services include assembly, packaging, sterilization management, and shipping to help get your device into your customers’ hands. We’re also experts in manufacturing line transfers, with a robust process in place to mitigate risk and ensure a smooth transition.
Bringing expertise & agility to customer relationships
With more than 25 years of experience and a deep knowledge of interventional device markets, we have what it takes to proactively lead you through every step of the product development process. As a midsize company, we’re agile enough to remain responsive and flexible but large enough to offer resources to scale as needed. Our team-oriented, customer-focused culture recognizes the importance of maintaining mutually beneficial relationships with customers as well as team members.
Specialists in manufacturing line transfers
If you’re looking to transfer your manufacturing line to expand capacity, reduce overhead, or consolidate suppliers, you’ve come to the right place. As a trusted partner, we’ve successfully managed hundreds of manufacturing line transfers for customers of all sizes. Our manufacturing line transfer process is structured to mitigate risk and avoid major pitfalls, yet flexible to allow for a customer-centric approach.
LEARN MORE
Comprehensive final assembly capabilities
As a vertically integrated partner, we can design and manufacture a wide range of engineered components and assemble them into a finished device. Our assembly capabilities encompass the full range of operations needed to produce a medical device, including:
  • Manual assembly
  • Adhesive, solvent & thermal bonding
  • Tipping
  • Pad printing
  • Ultrasonic welding
Full range of packaging solutions

We understand the importance of packaging to protect your medical device and ensure that it arrives safely at its final destination. Our comprehensive packaging solutions include:

  • Packaging design
  • Pouch sealing
  • Tray sealing
  • Backer cards
  • Laser labeling
  • IFU management
  • Kitting services
  • Shipper packaging
  • Palletization
  • Packaging validation, including:
  • Peel testing
  • Die penetration testing
  • Package integrity testing
Optimizing sterilization management

Our engineering team will work with you to develop and manage the optimal sterilization process for your device, including gamma, EtO, and e‑beam sterilization. We can also develop a product validation plan that complies with regulatory requirements. We have our own validated EtO sterilization cycle with weekly runs. Many new products can be qualified without a full validation. All test methodologies and procedures comply with ISO, USP, AAMI and/or customer-supplied requirements. Our services include:

  • Sterilization validation
  • Bioburden
  • Environmental process controls
  • Sterilization audit & release testing plan
Strategically located facilities

Our 12 facilities are in key medical device hubs to serve our customers. Our recently expanded Costa Rica facility offers high-volume, low-cost options, maximizing cost efficiencies throughout the process. With more than 220,000 square feet of cleanroom space across the company, we have the facilities, equipment and expertise to handle a full range of assembly needs in our technology Centers of Excellence.