Why Paramit?

Paramit is committed to serving medical device and life science instrument manufacturers. This focus on the medical industry has resulted in our team's obsession with correctness and doing things the right way, even beyond what our OEMs request or the FDA requires. Our philosophy permeates every aspect of the business and leads us to achieve an unparalleled level of operational excellence.

As an FDA-registered manufacturer of complex, finished medical devices, Paramit delivers confidence and certainty to medical device and life science instrument OEMs. We provide expertise in FDA compliance, mechatronics, fluidics, optics, test development, PC assembly, system assembly, and both functional and systems testing.

Medical Industry Focus

Many manufacturers have medical industry experience, but few, if any, are devoted to building medical devices and instruments, the way Paramit is. Medical device OEMs have unique requirements for technical resources, information systems, validated processes, product data, and regulatory compliance. Paramit understands and provides for all the complexities and constraints inherent in the medical industry.

Engineering Expertise

Paramit is an engineering-focused manufacturer with an extraordinary depth of technical resources, including electrical engineers, manufacturing engineers, RF engineers, and test engineers. In fact, nearly 20% of the Paramit staff are degreed engineers. Our engineering team serves as the foundation for all of Paramit's efforts to build high-quality, reliable, and cost-effective finished medical devices and instruments.

 

Quality Strategies

Paramit takes ownership for the product from New Product Introduction (NPI) through final system assembly and test. We put every product through a rigorous NPI process that includes a Design for Manufacturability (DFM) review, a Design for Testing (DFT) review, and a Failure Modes and Effects Analysis (FMEA) to identify and reduce the opportunities for defects. Through post validation testing, the NPI team confirms that we achieved the targeted results.

Paramit builds all system subassemblies and completed systems using our patent-pending compter directed assembly technology called vPoke. vPoke controls all inputs into basic elements of work, forces conformance to established criteria and sequences, and automatically documents everything for easy future referenuce during internal reviews and FDA inquiries.

During manufacturing Paramit uses tightly controlled, closed-loop work cells andstop-on-defect processes. When issues do occur, our manufacturing engineers resolve them in real time, on the spot. With offices on the shop floor, Paramit's engineers are never more than a few steps away from the operators on the line, allowing for better communication and workflow. This closed-loop system is key to quickly identifying and resolving all issues that impact product quality.

Paramit Differentiators

Product Ownership

Paramit takes full responsibility for every medical device we build, from working with the OEM engineers to ensure the design is manufacturable to designing and executing the final system test of the product.

PCA Process Validation

Although the FDA doesn't require it, Paramit performs process validation on all PCAs because it reduces costs and significantly improves the quality and, ultimately, the long term reliability of the final product.

Mechanical Assembly

Paramit's patent-pending, computer-directed mechanical assembly technology, vPoke, improves product quality and provides control and verification of every step of the manual assembly process.