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About Us

Reliable & Cost
Efficient Consulting

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INSYST SDN BHD is a professional training and consultancy firm dedicated to enhancing the quality and effectiveness of quality management systems. We specialize in providing consultancy and training services, particularly for Quality Management Systems such as ISO 9001, ISO 13485, Good Distribution Practice for Medical Devices, and more.

We also offer services in Medical Device Regulatory compliance, including medical device product registration, as well as Social Compliance Management Systems. Additionally, we provide general training to facilitate the understanding of international and national standards requirements, along with internal auditing services tailored to specific standards.

In today’s competitive corporate landscape, quality is a powerful tool for gaining a strong foothold and ensuring long-term success. Certification of a management system not only provides national and international recognition but also strengthens an organization’s commitment to customer satisfaction, ultimately enhancing its reputation in the corporate market.

Our History

Our Company Journey

  • 2017

    The Beginning

    The business was started as a small consultancy, focusing on helping establishments on getting their medical devices meet the Malaysia regulatory requirements.

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  • 2018

    Focusing on Medical Device Industry

    Our services expanded to include more medical device regulatory services which includes the ISO 13485 consultancy, trainings, catering to the growing healthcare industry.

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  • 2019

    Expanding Expertise

    We diversified into broader training services, adding compliance and regulatory consulting to our portfolio.

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  • 2020

    Recognition

    The business gained recognition for its expertise in medical device quality management, becoming a trusted partner for leading organizations.

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  • 2021

    Embracing Digital Training

    Amid global challenges, we adapted by providing online consultancy and training, helping clients stay compliant and competitive in a remote environment.

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  • 2022

    Gaining Momentum

    We built a strong client base by providing targeted training for international quality management certifications.

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  • 2023

    A New Era of Innovation

    With our experience and trainers expertise, we continue to innovate and evolve, focusing on enhancing productivity through quality management and regulatory compliance.

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  • 2024

    Incorporation and Growth

    Incorporated as INSYST TAC SDN BHD, we took a significant leap forward, expanding our team and offerings, including specialized training in ISO certifications.

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We build ideas driven by the future.