Master the requirements of the EU Medical Device Regulation (MDR 2017/745) with expert-led training designed for today’s medical device landscape.

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Our  EU MDR Training equips professionals with the clarity, confidence, and practical tools needed to achieve and sustain MDR compliance. This training provides practical, real-world regulatory guidance aligned with current EU MDR expectations. 🔍 What You’ll Learn:💠 EU MDR structure and key regulatory requirements💠Device classification and conformity assessment pathways💠Technical documentation (Annex II & III) requirements💠Clinical Evaluation, PMS & PMCF obligations💠Risk management and GSPR alignment💠Common MDR gaps and how to avoid them 👩‍⚕️ Who Should Attend:💠Regulatory Affairs and Quality professionals💠Medical device manufacturers and sponsors💠Start-ups entering the EU market💠Teams responsible for MDR compliance 📢 Expressions of Interest Now Open📩 Register your interest to receive training dates and course details📧 Contact us at: info@cmsscidoc.com

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This New Year, invest in your professional growth and strengthen your regulatory knowledge to stay ahead in the dynamic world of medical devices.

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CMS SciDoc invites Expressions of Interest for our Medical Device Training Programmes – 2026, designed to empower professionals with practical expertise and up-to-date insights into global regulatory requirements.Our programs are crafted and delivered by experienced medical device consultants, blending regulatory theory with real-world, hands-on application to help you achieve compliance confidence. Who should attend?💠 Regulatory Affairs & Quality professionals💠 Medical device manufacturers & sponsors💠 Start-ups entering the medical device market💠 R&D, Clinical, QA/RA, and Compliance teams Proposed training topics:💠 ISO 13485 – Quality Management Systems for Medical Devices💠 ISO 14971 – Risk Management for Medical Devices💠 Process Validation for Medical Devices💠 Medical Device Software💠 Auditor Training💠 Designing a Regulatory Compliant Technical File💠 Clinical Evaluation Report: Tips & Tricks💠 MDSAP[…]

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From Risk Identification to Risk Mastery — We’ve Got You Covered!

adminTGA Sponsor

In the high-stakes world of medical devices, managing risk isn’t just about compliance — it’s about protecting patients, your reputation, and your innovation. At CMS SciDoc, we provide a complete risk management solution that goes beyond assessment to empowerment. Our experts not only perform comprehensive risk assessments for your medical devices, but also equip your team with the knowledge and skills to manage risk confidently through our specialised 2.5-day Risk Assessment Training Program. Expert Risk Assessment Services Our consulting team helps you uncover, evaluate, and control potential hazards across your device’s lifecycle — guided by ISO 14971, FDA, MDR, and TGA requirements.We ensure your risk files are complete, defensible, and audit-ready. Services include:💠 Product risk analysis[…]

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TGA proposed changes to the Regulation of Assistive Technologies

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The new TGA document, Consultation: Proposed Changes to the Regulation of Assistive Technologies, seeks feedback on the current provisions in the Therapeutic Goods Determination 2018. These provisions classify “household and personal aids, or furniture and utensils for people with disabilities” as excluded goods, meaning they are regulated as consumer goods instead of therapeutic goods.

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