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Most medical device companies struggle with one critical question during an audit: When should a CAPAR actually be initiated? Last week, ARG Academy had the privilege of guiding 7 dedicated professionals from MyMedic Innovation Sdn Bhd through our ISO 13485:2016 Understanding and Internal Audit training. Their goal was clear: to enhance the competency of their […]

Compliance shouldn’t be a reactive scramble. It should be a proactive strategy. 🛡️ When the new ISO 11137-1:2025 revision was released, GRAND TEN HOLDINGS SDN BHD didn’t hesitate. They partnered with us at ARG Academy to ensure their team was “ever-ready” to adopt the latest requirements. Over two intensive days, we had the privilege of […]

We are pleased to share that ARG Academy successfully conducted a 𝟱-𝗱𝗮𝘆 𝗶𝗻-𝗵𝗼𝘂𝘀𝗲 𝘁𝗿𝗮𝗶𝗻𝗶𝗻𝗴 𝗽𝗿𝗼𝗴𝗿𝗮𝗺 𝗳𝗼𝗿 𝗖𝗖𝗕 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗦𝗱𝗻 𝗕𝗵𝗱, held from 𝟮𝟱 – 𝟮𝟵 𝗔𝘂𝗴𝘂𝘀𝘁 𝟮𝟬𝟮𝟱. This program was designed to strengthen knowledge, skills, and compliance in sterile medical device manufacturing, focusing on:✅ Sterilization methods with emphasis on Ethylene Oxide (ETO) sterilization.✅ Validation and […]

Manufacturing Process Validation for Medical Devices Training📅 14 August 2025 | 📍 Sem Matic Sdn Bhd | 👥 18 Participants ARG Academy had the privilege to deliver a focused training on Manufacturing Process Validation for Medical Devices, equipping participants with practical knowledge to strengthen regulatory compliance and process effectiveness. The program emphasized key elements of […]

Manufacturing Process Validation for Medical Devices Training📍 TDK-Lambda Malaysia Sdn Bhd | 7 August 2025👥 18 Participants ARG Academy had the privilege of conducting a focused training on Manufacturing Process Validation for Medical Devices with the enthusiastic team at TDK-Lambda Malaysia Sdn Bhd. The session emphasized:✅ Process qualification & control strategies✅ Risk-based validation approaches✅ Regulatory […]

Awareness Training on ETO Sterilization – ISO 11135:2014📍 Emerald Medical Services | 4–5 August 2025👥 5 Participants ARG Academy had the opportunity to conduct a 2-day Awareness Training on Ethylene Oxide (ETO) Sterilization – ISO 11135:2014 with the dedicated team at Emerald Medical Services. The program highlighted key aspects of:✅ Sterilization process qualification & validation✅ […]