Components & Devices
IV Device Components to Meet
Intravenous Medical Devices
Intravenous (IV) medical devices are one of the most technically challenging product lines to produce. Most IV device parts are very small and have extremely tight specifications and tolerances. BMP Medical utilizes it’s expertise in statistical process control, automation, decoupled molding processes, and quality control procedures to manufacture these components. With tolerances that are often times +/- 0.0005”, precision manufacturing and QC techniques are utilized to ensure the product meets specification and does not pose any safety concerns to the customer. Validation (IQ, OQ, PQ) is imperative at the beginning to establish that tight process window required to produce these parts. We work closely with our OEM customers to provide the documentation and protocols necessary for this validation process.
In-Vitro Diagnostic Medical Devices
BMP Medical has been producing components for In-Vitro Diagnostic (IVD) medical device testing for over 30 years. Many of the parts that we have developed with our customers have very intricate designs and features that set them apart from other products on the market. We work closely with our customers to provide support on the design and the ability to manufacture their products. IVD parts we produce include lateral flow filtration devices, Polymerase Chain Reaction (PCR) vessels, and sample transport containers. The key to manufacturing an IVD device is color. Many of the IVD tests that these devices are used for require a visual color interpretation, and if the part color is slightly off, the test may be interpreted incorrectly. This requires innovative methods to produce the proper color in our processes to meet our customer’s needs.
Class I Medical Device
BMP Medical is an FDA registered medical device manufacturer (listed under Biomedical Polymers). We specialize in Class I exempt medical devices. There are currently 6 product lines of Class I medical device products with several more in development. BMP Medical also manufactures parts that are used in Class II and Class III medical devices as OEM products for several customers. All products are manufactured under our ISO 13485:2016 certified Quality Management System. BMP Medical utilizes both classic and state-of-the-art metrology and inspection systems to meet the strict quality requirements for these medical devices.
Sample Preparation Device
Design and Testing
In certain circumstances, to increase the sensitivity of an assay, or just to simply purify a test analyte, customers need to use sample preparation devices. These devices are generally a tube-based device with either a manual or gravitational action that draws the sample through a filter or purifying material to clean up the sample. With our OEM partners, BMP Medical has been able to help with the part design, materials of construction, and other functional parameters necessary for the production of high-quality devices that function as designed.
Related Links: Custom Plastic Injection Molding Manufacturer | Development & Design | Design & Engineering Consultation | Components & Devices: IV Device Components, Class 1 Medical Device Manufacturing, Sample Preparation Device Design & Testing | Manufacturing: Cleanroom Manufacturing, Assembly & Packaging, RNase/DNase Free Manufacturing Services | Custom Packaging Solutions | Process Validation, Quality | Material Expertise
- DNase/RNase Free Production
- Clean Room Production
- Sterile Product
- Custom Material Selection
- Functionality Testing
- Sonic Welding