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.
One of the best benefits of having a Turnkey Production Partner when you're in the Medical Industry? You have ONE company managing the supply chain, manufacturing, assembly and production of your technology. Rather than managing multiple fab-shops, consolidate all that work to one organization who will manage it for you.
When you work with a Full-Service organization, communication is open throughout the facilities. When outsourcing to a handful of small-sized machine shops, you rely on having to organize time frames from each shop. When companies work with PEKO, they have one point of contact, their dedicated Program Manager who is the biggest internal advocate for our customers' success. And since Medical Devices require quality checks throughout their processes, by utilizing a Contract Manufacturer, companies can relocate their focus on more important aspects of their businesses.
Quality Assurance & Quality Control
Especially when it comes to manufacturing Medical Devices, if parts or assemblies are not meeting proper specifications, the end-user can find themselves in a life or death situation. Due to the severity of such consequences, our Quality Management Teams follow rigorous guidelines that OEMs and CMs alike must follow and abide by to ensure a technology's success in the market place.
- The Quality Control Team should be involved through various stages of component fabrication all the way through assembly and throughout the shipment stages. During our on-boarding stage, PEKO defines what criteria needs to be tested at each stage through manufacturing. For example, one of PEKO's Medical Customer's designed a large, complex MRI machine. This means that PEKO's Quality Control team is responsible for quality checks on post manufacture components, any purchased parts, and all of the electrical and software units we have assembled. While this process may take more than 40 hours, it is essential to making sure the product is safe when it will be used in the medical field.
- The Quality Assurance Team is involved with providing clear and traceable documentation with every part and process involved with manufacturing a Medical Device. Documentation is an important aspect of manufacturing as a whole, but when it comes to devices for the Medical Industry everything needs to have clear traceability. The reason for this is simple: If anything were to go wrong with the device once it was in use, we would need to understand root cause.
The special care placed on manufacturing and assembling component parts for Medical Devices needs to be followed through into the packaging. While importance is placed on making components, we need to know the sub-assemblies will make it to our customer, free of defect, as it could have serious implications on the end-user if anything happened during transit. This involves using proper packaging materials and crating to ensure safety of the product during shipment. In some instances, PEKO has made our own crating so our manufactured Medical Devices can make it to the end-user safely. In other instances there may be customer requirements on shipping in regards to environmentally safe packaging materials in which we are happy to comply with.
PEKO has always been aware of the risks and enormous responsibility that comes with producing Medical Devices. All members of our PEKO team take great pride in the work we do because we know the effects medical technology and medical devices have in our community. We understand that even the personnel producing a medical device might someday have to rely on that same device to save their life or the life of a family member. That community dependence on safe, accurate and reliable Medical Devices influences how we structure our Quality Management System so that we can meet strict regulatory compliance and provide satisfaction to our customer and ultimately the end Medical Device user.
If you are interested in outsourcing your Medical Device manufacturing to a Contract Manufacturer, check out our FREE checklist to help you get started!