Manufacturing
Services
Biotex is an FDA-registered and ISO 13485:2016 certified medical device manufacturer and can serve as a contract manufacturing partner for our partners once the product is cleared for marketing. The reality for most new technologies is that manufacturing needs remain low during initial market introduction, which may be difficult to source from conventional contract manufacturers. We can perform pilot or small-scale manufacturing and grow with our clients as their needs evolve.
From development to production.
A single source solution.
Transferring from Design Controls to a validated medical device manufacturing and packaging process ensures continuity as the product is commercialized. This vertical integration helps reduce costs, mitigate risks, streamline the supply chain, and ensure consistent quality.
Design Verification and Validation Builds
Component manufacturing, assembling, and packaging are all built with complete batch traceability and quality controls for various validation activities like sterilization, biocompatibility, and packaging.
Process Qualification Builds
Every step in our manufacturing process is validated to ensure that the finished product meets all design characteristics, leading to the consistent delivery of quality products.
Clinical Study Builds
We understand that medical device design is an iterative process. Our highly flexible manufacturing teams build customized builds to gain valuable clinical data.
Supplier Qualification
Our QC team employs a comprehensive program to qualify our global suppliers by auditing their quality management systems.
Global Component and Assembly Sourcing
We leverage our deep supply chain to source critical components built with reliable and scalable manufacturing processes.
Supply Chain Optimization
Our extreme focus on logistics encourages value-added work with qualified vendors. It minimizes manufacturing, transportation, and distribution costs.
