The process to ensure successful Medical Device Assembly for Medical programs begin when the program is accepted. When you outsource a Medical Device to a Contract Manufacturer, follow these 6 critical steps to guarantee the success of your program once it's transitioned over to the full-scale assembly phase.
The term "Medical Device," is a broad term that can have a few different meanings. Depending on how the device will be used, there are different classifications to determine quality assurance that is associated with the device's manufacturing. Classifications of Medical Devices refer to Class I, Class II, and Class III which differentiate the level of risk associated with the device as well as the level of regulatory controls required during manufacturing.
Regardless of their classification, Medical Devices have touched every person's life in one way or another. And whether or not they have specifically saved our own lives, it's safe to assume they have saved the life of someone we love. This is how important our company treats the manufacturing of Medical Devices and this sentiment is felt through each and every person who works on our Medical Device projects within our organization.
The Quality System is the backbone of a successful and repeatable manufacturing system. The strongest companies employ a QMS that oversees all facets of the contract manufacturing operation. With these systems in place, products can be built repeatably each and every day, dramatically reducing the chance of discrepant products ever reaching the customer destination.
Back in November, we shared our new inspection Coordinate Measuring Machine as part of our new machinery updates. Since that blog post, we have finished the installation of our brand new climate controlled room to house this new machine. Since PEKO has been expanding its output, our need to increase our inspection capabilities has expanded as well.
New Inspection Capabilities
PEKO's newest machinery announcement is an exciting new addition for our inspection department. After overcoming a few obstacles with its delivery, the new DEA CMM now sits inside the center bay of our Engineering and Development Center. The machine's height is over 14 feet, with an impressive measuring range over its 3 axes:
- X-Axis: 59.06"
- Y-Axis: 78.74"
- Z-Axis: 55.12"
The machine comes equipped with a Renishaw PH10MQ Probe along with CLIMA Temperature Compensation. These are beneficial accessories when installed into its new home, a climate controlled room around this new addition.