At MDI, we strive to provide all of our customers with precision, quality controlled, and expertly designed and manufactured plastic components. This is true for all of our services, but it is particularly relevant in the production of medical devices and equipment components.
Medical products, unlike equipment in many other industries, must go through rigorous testing, validation and verification processes. We are an ISO 9001 certified company, and we also have ISO 13485 certification, which is specific to medical industrial design and production quality control standards.
Quality Control Starts at the Concept
While our team of medical industrial design engineers can enter the process at any time, it is beneficial for a medical device manufacturer to bring our team in early. This allows our engineers to provide valuable insight into the entire medical device product development model. We can help with the rigorous process, and ensure that it is appropriately documented, validated, and verified.
Once the drawing is approved, and the initial research and testing on the design are completed, we can then move into the prototyping phase.
While virtual testing of the design is effective, there is still the need for prototyping in the medical industrial design model before moving into production.
Prototyping using the lowest cost and highest quality methods is critical. These prototypes have to be precision crafted, which means expertly designed and tooled molds or processing methods have to be in place. For most medical devices, there will be a requirement for all prototyping, and the eventual production to be completed in clean rooms, a service that MDI can provide.
The final step in moving a medical device from concept to production is the testing phase. The prototypes are critical for this, allowing for final approval and ensuring the device meets all FDA regulations based on the class to which it belongs.
Approval on new medical devices is a complicated and lengthy process. By working with MDI in the industrial design, prototyping, and production phases, we can assist in streamlining the process. For more information on our services, get in touch with us today at 800-852-1472.