Quality
At Paramit quality is not simply a by-product of compliance, but the result of an obsession with correctness, thoughtful planning, and rigorous implementation of processes and strategies designed to eliminate product defects. Paramit encourages innovation at every level in the organization and aggressively pursues the best ideas for improving quality. Ownership from PCAs to Finished ProductParamit takes ownership of every product we manufacture. The entire manufacturing process takes place under one roof where we can control the quality of every aspect of production. Learn more. Defect PreventionParamit consistently maintains a less than 10 defects per million opportunities (DPMO) for PCAs. We achieve this quality level by reducing defect opportunities and defects at every stage. During New Product Introduction (NPI) we do a Design for Manufacturability (DFM) review and perform a Failure Modes and Effects Analysis (FMEA) on every product Paramit manufactures. We use stop-on-defect analysis and closed-loop work cells that prevent products with failures from moving down the line until the defects are resolved. We design and execute state-of-the-art test solutions to verify the integrity of the PCAs and our highly qualified team of electrical engineers with design-level experience create functional tests and train operators to perform them. Process ValidationEvery manufacturer knows that a high PCA test yield does not necessarily guarantee high quality boards. A board that passes functional test without a problem can just as easily cause a failure in the finished product. To address this issue, Paramit performs process validation on all printed circuit board assemblies. We have found that PCA process validation is a key to ensuring a board's quality and improving the long term reliability of the finished product. Learn more.
| vPoke Computer-Directed Mechanical AssemblyThe mechanical assembly procedures used in medical devices and instruments are complex, manual sequences with a high likelihood of error. Paramit virtually eliminates this variability with vPoke, our proprietary computer-directed mechanical assembly technology. vPoke guides the operator through assembly sequences, ensures conformance to standards, and automatically creates an FDA-compliant, electronic device history record. Learn more.
Test SolutionsParamit's sizable staff of electrical engineers and test technicians has extensive experience creating and streamlining test solutions that efficiently and cost-effectively test both PCAs and completed systems. Our highly skilled engineers take responsibility for the product and solve problems independently, without siphoning test resources away from the OEM. Learn more. |
Registrations and Certifications
ISO 9001:2008 - UL DQS Registration Number 10002924 QM08 |
FDA/GMP - FDA Registered Number 3003537036 |
State of California - Medical Device Manufacturing License Number 50087
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IPC Certification - Lead Free Electronics Assembly Process Capable |
