ISO Training
Our accredited trainers with years of hand-ons industry experience are open to give advice and consult based on ISO requirements.
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ISO 13485
Quality Management System (QMS)
ISO 13485:2016 are requirements for a Quality Management System (QMS) for medical device industry.​ It focuses on delivery of medical devices that are safe for their intended purpose.
The standard ensures compliance with regulatory requirements and enhances product quality and safety.
ISO 17025
Introduction to Implementation of the Laboratory Quality Management System
ISO 17025 focuses on establishing a Laboratory Quality Management System to ensure consistent, reliable testing and calibration results.
It involves complying with international standards, to enhance laboratory credibility and foster customer trust in its services.
ISO 14971
Application of Risk Management to Medical Devices
ISO 14971:2019 outlines a framework for applying risk management to medical devices.
It focus on risk management throughout a device's lifecycle, ensuring patient safety.
The standard guides manufacturers in making informed decisions to enhance healthcare outcomes.
ISO 11135
Ethylene Oxide Gas Sterilization
ISO 11135:2014 provides comprehensive guidelines for ethylene oxide gas sterilization in the healthcare industry. It covers the requirements for sterilization process for medical devices.
This standard ensures device integrity, essential for patient safety and regulatory compliance.
ISO 11607
Packaging for Terminally Sterilized Medical Devices
ISO 11607 outlines requirements and test methods for packaging terminally sterilized medical devices.
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It ensures packaging is suitable for sterilization, provides physical protection, maintains sterility up to the point of use, and is materials-safe.
This standard is vital for device safety, effectiveness, and regulatory compliance.
Advancement trough training
We provide:
Diverse learning methods:​
classroom-based, virtual, and blended courses
Industry-specific solutions:
tailored training for medical device manufacturers and sterilizers
Customized learning:
bespoke training solutions based on industry needs
Standard-based training:
comprehensive ISO and other standard-specific courses
Specialized subject training:
covering microbiology techniques and validation of test methods
Industry-experienced trainers: