POONGLIM Pharmatech 홈페이지에 오신것을 환영합니다.



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Overview

OUR COMMITMENT TO HIGH QUALITY

poonglim pharmatech is As a manufacturer of medical devices according to the FDA and the Ministry of Food and Drug Safety's quality standards, the organization implements an internationally recognized medical device quality control system and implements all validation systems applied to the manufacture of products, such as medicines and medical devices, to establish quality manuals, procedures, etc. so that products of the highest quality can be produced consistently under optimal functional conditions, and to ensure that all products of the quality are systematically executed and that they are verified.

  • R&D NEW PRODUCT DEVELOPMENT
    R&D NEW PRODUCT DEVELOPMENT
    Best choice for professional product development
    - Design design for a wide range of medical device products
    - Designing, drawing, and product development of new products
    - Customized R&D for product characteristics
    - Establishing a design qualification assessment
  • QUALITY MANAGEMENT
    QUALITY MANAGEMENT
    GMP Basic Quality Control System of the Ministry of Food and Drug Safety
    - Establishing inspection of raw materials and material warehousing
    - Establishing facility qualification assessment
    - Inspection equipment and instrument calibration
    - Regular monitoring of clean rooms
  • PRODUCTION
    PRODUCTION
    Production of products through clean facilities and facilities
    - Applying clean room ISO7 and ISO8 for major courses
    - Establishment of validation evaluation for production process
    - Applying standard specifications for production procedures
    - Establishing an instrument calibration system
    - Monitoring of the anti-temperature moisture in the ware storage warehouse
  • CERTIFICATE RELATED
    CERTIFICATE RELATED
    glass injection HL-type TR-type quality control system
    - GMP certification by the Ministry of Food and Drug Safety in the quality control system
    - International Standard ISO 13485 Certification. CE and FDA certification
    - 28 domestic and international patents and 38 design patents.
    - Issuing the entire process quality report

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