Compliance
As an FDA-registered and ISO-certified manufacturer of complex finished medical devices, Paramit regularly examines and assesses systems and records to confirm that our company, products, processes, and documentation are in compliance with 21CFR820 and ISO 13485 regulations, thereby ensuring our preparedness for an FDA audit. Paramit maintains a staff of internal auditors who are certified in QSIT (Quality Systems Inspection Technique) and we use an outside audit team of former FDA inspectors to regularly evaluate our manufacturing and recordkeeping processes for compliance.
Quality System Regulation The FDA requires every medical device manufacturer to define and implement methods and processes that result in the consistent production of safe and reliable devices whose quality can be objectively measured and verified. Due to the wide variety of medical devices, the FDA regulations are intentionally nebulous and rely on the "good judgment" of medical manufacturers to create effective manufacturing processes. | Based on our long-standing experience with medical device manufacturing, Paramit understands how to create quality manufacturing processes that meet FDA regulatory requirements. While the FDA regulations provide a solid base for validation and traceability, in some cases we find value in going beyond those regulations. For example, Paramit performs process validation on all PCAs and we automatically create a device history record during mechanical assembly. Learn more about Paramit's fanatical devotion to quality. Device History RecordTraditionally, a device history record is associated with significant costs in terms of human capital, space, process overhead, and even paper. Seeing an opportunity for innovation, Paramit created a patent-pending, computer-directed assembly technology called vPoke. vPoke not only virtually eliminates manufacturing defects from the assembly process but also automatically creates a device history record in real time as each sequence is completed. Paramit's electronic device history record can be accessed at any time by product serial number and sequence. Learn more.
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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 |
