Quality System Regulation

Paramit is a finished diagnostic and instrumentation device manufacturer. Our QMS is certified to the new ISO 13485:2016 standard. Paramit regularly examines and assesses systems and records to confirm that our company, products, processes, and documentation are in compliance with FDA 21 CFR 820 as well as meeting international regulatory requirements, such as Japan PAL MHLW MO 169 and Korean KGMP. Paramit maintains a staff of internal auditors who are trained in QSIT (Quality System Inspection Techniques) and we use outside quality/regulatory consultants to regularly evaluate our systems to ensure our QMS meets various regulations for a variety of medical devices (RUO, Class II and III). Based on our long standing experience with medical device manufacturing, Paramit creates quality manufacturing processes that meet FDA and international regulatory requirements. Paramit QMS also supports product safety certifications by UL, TUV, ETL, CSA, NEMKO, and the CE-mark certification for medical devices we manufacture.

Medical Device Experience

We Manufacuter Finished Medical Devices

Process Validation and Process Controls

Paramit’s validation program follows FDA Process Validation Guidance: General Principles and Practices. We perform validations (IQ, OQ, PQ) as part of our qualifications plan for PCBAs, finished devices and instruments which have proven the highest quality level can be achieved consistently in the production phase.  We create a comprehensive Master Validation Plan (MVP) for every manufacturing process including manufacturing equipment, customer tooling, test fixtures, and software validations. Every key manufacturing process has a Quality and Process Control Plan where the control methods, records, and metrics are identified as well as a reaction plan when a non-conformance occurs.

Master Validation Plan – Process Types and Description

PCB board

PCBAs are custom manufactured to customer specified requirements with accommodating quantities and test requirements

Systems Supporting Basic PCBA Assembly

Covers from component to partial or full assembly. Surface Mount Technology (SMT), Path Through Hole technology (PTH), Manual Soldering, BGA rework, and washing.

Equipment Types: Stencil Printer, Pick & Placement Machine, Reflow Oven, Wave Machine

Minimum Validation Required: IQ/OQ

Manufacturing Test Systems

Automatic Optical Inspection (AOI), Automatic X-Ray Inspection AXI, In-Circuit Test (ICT).

Equipment Types: In-Circuit Tester, Automated X-Ray Machine, Automated Optical Inspection Tester

Minimum Validation Required: IQ/OQ

Functional Tests

Test fixtures and protocols related to customer PCBA testing: Functional Unit Test (FUT), Functional Test (FUTD), Environmental Stress Screen (ESS), HALT/HASS.

Equipment Types: Varies per customer specifications

Minimum Validation Required: IQ/OQ and PQ – Product Specific (Established by customer)

vPoke Manufacturing

Mechanical Assemblies are custom manufactured to customer specified requirements with its accommodating quantities and test requirements

Manual Mechanical Assembly

Manual mechanical assembly process for mechanical subassemblies and system builds using customized tooling and procedures unique to customer specified requirements.

Equipment Types: Visual Poke Yoke (vPoke) System Stations

Minimum Validation Required:  IQ/OQ (V-Poke), PQ – System Suitability for Product Specific parameters (includes custom tooling verification)

System Test

System Test – Power up and test functionality of subassemblies or devices

Equipment Types: Varies per customer specifications

Minimum Validation Required: PQ – Product Specific (Established by customer)

Mechanical Engineers

Customer Developed Tests

System Tests for Customer Production Units

Functional Test Instruments (customer developed release test per instruments design)

Equipment Types: Various – (customer developed release test procedures per instruments design)

Minimum Validation Requirements: System Suitability Qualification, Test SOP, Required Fixtures/Checklists

Manufacturing Testing

Internally Developed Tests

Functional Test Fixture

Equipment Types: Internally Developed Test Fixtures

Minimum Validation Requirements: IQ/OQ, PQ – Product Specific (Established by customer)

Software

Software

Product Software

Product Software comprises of embedded software in manufactured assemblies installed as part of the devices functionality and is performed as part of the functional systems level tests.

Equipment Types: Varies per customer specifications

Minimum Validation Requirements: Established by customer and verifies performance of test at Paramit

Non-product Software

Non-product software comprises of software used in the collection measurement of quality data throughout the process and is supported a by hardware IT infrastructure. The software can be either online or operated from a local server. Non-product software can be custom made and/or off-the-shelf.

Equipment Types: 

ERP System (Inventory control*/Quality data/Financial & Business data), Label Printing Software – Minimum Validation: IQ/OQ

System Software controlling equipment – Minimum Validation: Validate Concurrent to System’s Qualification

Software Used in Calculations/Off-The-Shelf Software – Minimum Validation: IQ/OQ

Industry Standard Compliance

Product Design and Development

Paramit develops products in compliance with industry standards and has been ISO certified since 1998. The design and engineering processes we follow during development are compliant with either FDA Quality System Regulations or the relevant international standards for your specific product. We can readily adapt our quality system to use your existing systems, or apply our own compliant quality system if yours are still under development.

Compliant design control and product development process.

Manufacturing

Paramit is an FDA-registered and ISO-certified manufacturer of medical devices and instrumentation. We regularly examine and assess systems and records to confirm that our company, products, processes, and documentation are in compliance with 21CFR820 and ISO 13485 standard.

Device History Record with vPoke

Traditionally, 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 patented, computer-directed assembly technology called vPoke. vPoke not only eliminates manufacturing defects from the assembly process but also automatically creates a device history record in real time as each sequence is completed.

If in the future a device fails in the field and you want to review the manufacturing process history for that device, we simply enter the product’s serial number to access and automatically generate the entire device history record, including picture images for each sequence. Going well beyond the industry standard for compliance documentation, vPoke lets us handle any inquiry for our clients.

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