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    Home / Integrated Solutions / MAH

    One-stop CDMO Platform

    Integrated Solutions

    Salt Medical is committed to building the world's leading medical device CDMO company, providing customers with high-quality one-stop solutions.

    Design Service & Rapid Prototyping

    SALT has extensive experience working with leading medical device companies, focusing on innovative medical technologies, providing total solutions for design, engineering and medical manufacturing, managing risk throughout the development process, and accelerating time-to-market in a cost-effective manner.

    Experienced Technical Team

    Located in Galway, Ireland, Salt's innovative R&D centre is home to a team of materials and process experts with decades of experience in the custom development of innovative medical devices, using cutting-edge technology to provide high-quality, efficient prototyping work to support customers in seizing the market opportunity.

    Comprehensive Testing Services

    Located in Galway, Ireland, Salt's innovative R&D centre is home to a team of materials and process experts with decades of experience in the custom development of innovative medical devices, using cutting-edge technology to provide high-quality, efficient prototyping work to support customers in seizing the market opportunity.

    Clinical Advisory Board

    Salt is comprised of engineers and physicians, and has established a Physician Advisory Board in the cardiac and vascular fields to evaluate and advise on new products and technologies. Rapid clinical feedback ensures project feasibility and helps customers to address unmet clinical needs.

    Cost Control

    Decisions made during the design phase determine 80% of a product’s cost. The Salt team sets low-cost mass production as the ultimate goal from the design phase, providing customers with a wide range of materials and processes to choose from, and infiltrating the concept of cost control into every steps.

    DFX (Design for Excellence)

    Salt's technical team uses rigorous design processes to identify key features, simplify design, and optimize production processes to minimise production costs.

    Quality & Regulatory

    Our commitment to quality ensures that our products and services meet or exceed the highest standards set by the National Medical Products Administration (NMPA), Food and Drug Administration (FDA) and the European Community, assisting customers with global registration for medical devices and risk control throughout product life cycle.

    Cost Control

    • ISO 13485
    • Good Manufacturing Practices (GMPs)

    Medical Device Registration

    • FDA
    • CE
    • NMPA

    Product Life Cycle Risk Control

    • Pre- and post-production product contamination surveys
    • Chemical Analysis / Material Analysis / Coating Analysis

    Volume Manufacturing

    The Salt team has many years of experience in building production lines and mass production of polymer and metal products, and can provide customers with the most cost-effective bulk product supply through the supply chain systems and production lines layout covering various countries.

    MAH

    Leveraging a robust quality system and large-scale production capabilities, SALT helps customers navigate the product listing process under the MAH system. By undertaking production as a trustee, SALT significantly reduces customer's capital and time expenditures, while also mitigating operational risks.

    Improve Concentration

    Commissioned production unbundles the registration and production of medical devices, allowing customers to focus more of their efforts on R&D to overcome technical challenges.

    Cost Reduction & Efficiency Improvement

    By outsourcing production, the customer can save on equipment, facilities and quality control costs, while also shortening the product launch cycle.  The production department oversees the manufacturing process, which can enhance the efficiency of the production line.

    Integration into the Global Market

    The Salt team will help our clients successfully integrate into the international market by promoting and replicating the proven MAH approach.
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    Contact Us

    • Tel: +353 91 373884
    • Mail: info-irl@saltmedtec.com
    • Address:
      Unit 18, Claregalway Corporate Park, Claregalway, Co. Galway, H91 KFX3
    ©2024 Salt Medical. All rights reserved.