Quality Management System
Paramit’s Quality Management System is based on requirements stated in ISO 9001, ISO 13485, cGMP/QSR/21 CFR 820, Japan PAL, and Korean GMP standards.
For over four years, Paramit has achieved virtually zero-defects (<1 DPMO) in mechanical assembly. In SMT assembly, we’ve achieved 9 DPMO for over eight years, surpassing the industry best in class standard of 30 DPMO. Paramit’s defect prevention processes include:
- Design for Manufacturability (DFM) review and Failure Modes & Effects Analysis (FMEA) are performed during New Product Introduction (NPI) on every product.
- Tightly controlled, closed-loop work cells and stop-on-defect processes that are key to quickly identifying and resolving all issues that impact product quality.
- Design and execution of state-of-the-art test solutions to verify the integrity of PCAs. Our team of electrical engineers with design-level experience create functional tests and train operators.
- Real time resolution of issues when they occur by manufacturing engineers. Paramit’s engineers are never more than a few steps away from the operators on the line, which allows for better communication and workflow.
- Validations (IQ, OQ, and PQ) performed in our qualifications plan for PCBAs and instruments are achieved consistently in the production phase.
vPoke Mechanical Assembly
Paramit builds all subassemblies and completed systems using our computer directed assembly technology called vPoke. vPoke controls all inputs into basic elements of work, forces conformance to established criteria and sequences, and automatically documents a device history record (DHR) for future reference during internal reviews and external inquiries. This virtually eliminates all variability associated with the complex, error-prone manual assembly sequences commonly used in medical devices and life science instrumentation manufacturing.
- FDA QSR
- Design History File
- Device Master Record
- Human Factors Analysis
- ISO 9001 Certified
- Take product to CE mark
- IEC 60601 and 61010
- Documented Design Standards
- ISO 13485
- ISO 9001:2015 – UL DQS Registration Number 10002924 QM15
- ISO 13485:2016 – UL DQS Registration of Quality Systems for Medical Devices. Registration Number 10002924 MP2016
- FDA/GMP – FDA Registered Number 3003537036
- State of California – Medical Device Manufacturing License Number 50087
- IPC Certification – Lead Free Electronics Assembly Process Capable
- Product safety compliance with UL, TUV, CSA, ETL and NEMKO certification