Medical Device Assembly
Transforming your components & sub-assemblies into a finished medical device.
When it comes to assembling your medical device you want to partner with someone you can trust. Someone who takes ISO 13485 regulation seriously. Someone who follows good manufacturing practice for medical devices (21 CFR Part 820). Someone who strives every day for continuous improvement.
Here at JunoPacific, we cultivate such a culture through our operational excellence programs. These include:
- Continuous flow manufacturing
- Visual process controls
- Documented employee training for our highly skilled operators and technicians
- Traveler and line history report generated for each build
- Dedication to the principles of lean manufacturing and 5S
- Kanban for fast response and lower inventories
- Kaizen for cost reduction and performance requirements
JunoPacific also offers a wide range of product packaging capabilities: everything from bulk pack to a fully kitted and assembled product which we ship direct to offsite sterilization.
Some of the key features in our assembly and packaging process include:
- Clean room assembly in both Class (7) 10,000 and Class (8) 100,000 environments
- Manufacturing pilot lines to debug, analyze, validate compliance and finalize for production
- Process Failure Mode and Effect Analysis (FMEA)
- Epoxy/UV curing assembly, mechanical assembly, part pouching and sealing, and tray sealing from sub assembly to delivered, finished, sterile devices
- Verification and validation testing; tensile, compression, and torque testing; leak testing by pressure decay and flow rate
- Heat staking and ultrasonic welding
- RFID tagging
Tracking the Paper Trail
Traceability and Accountability
In medical device assembly it is important to have a clear trail of paperwork to follow from the manufacturing of the individual device components all the way through sterilization verification.
First we create and define a process via standard operating procedures (SOP), manufacturing processing instructions (MPI), and/or assembly instructions (AI). Next, we formulate a validation master plan (VMP) where we define the required verifications needed to validate the defined process. We then carry out these tests and even validate our test methods. All of our validations are done with statistical methods. Finally, we create a device history record (DHR) or a traveler which acts as a routing document for each assembly. This ensures all processes were followed according to good manufacturing practice (GMP), including signatures and dates for each step and in process QC check. This document contains the how, who, what, where, and when of the assembly process. A manufacturing engineer is assigned to each project to review and verify all paperwork is properly filled out with the appropriate signatures to guarantee this traceability.
With this complete documentation system each component can be tracked back to when and by who did a specific assembly and QC step, and for plastic parts we can trace each piece all the way back to the lot of material it was produced from and which machine molded the part. This way you can be sure your device meets all FDA regulations for manufacturing.
If you only need a single component, or a ready to use minimally invasive surgical tool, JunoPacific has the expertise and bandwidth to meet and exceed your every requirement.