Preparing Technical Documentation for TGA or MDR can be complex, time-consuming, and overwhelming — especially when requirements are constantly evolving. Errors or gaps can lead to delays, non-conformities, or even rejection. At CMS SciDoc, we provide end-to-end support to ensure your Technical File is complete, compliant, and audit-ready — while also equipping your team with the knowledge to maintain it confidently. 🔹 Technical Documentation Preparation We develop high-quality, regulator-ready Technical Files tailored to your device and target market requirements, including: • Device description and specification • Intended purpose, indications & contraindications • Risk management documentation (ISO 14971 aligned) • Clinical evaluation / performance evaluation support • Biocompatibility and pre-clinical evidence planning[…]

Under the Therapeutic Goods Administration (TGA) regulations in Australia, some Clinical Decision Support Systems (CDSS) may be considered exempt medical devices — but only if they meet specific criteria. A CDSS is only considered exempt if it meets all three of these: ✔️ It supports or provides recommendations to a health professional (e.g. for prevention, diagnosis, or treatment) ✔️ It does not directly analyse medical images or signals from another medical device ✔️ It does not replace the clinical judgement of a health professional 🚨 With the rapid uptake of AI in healthcare, it’s critical to note that AI-enabled CDSS will NOT meet the exemption criteria. 👉 If your software[…]

Join us May 5–6 – Contact us today to reserve your spot! Unlock expert-level mastery of ISO 13485:2016 with our intensive two-day workshop, designed for medical device professionals seeking excellence in quality management, compliance, and patient safety. 🔍 What You’ll Gain – In-Depth Learning Outcomes ✅ Core Purpose & Impact Understand why ISO 13485 is the global benchmark for medical device QMS Learn how risk-based thinking drives continuous improvement across design, production, and distribution ✅ Clause-by-Clause Mastery Walkthrough of all key clauses: leadership, resources, design controls, supplier management, post-market surveillance Real-world case studies and examples ✅ Practical Implementation Toolkit Hands-on guidance: process mapping, risk assessments, internal audits, corrective actions Minimize nonconformities and recalls ✅ Global[…]

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📧 Contact us at: info@cmsscidoc.com

A well-developed Regulatory Strategy is the key to avoiding delays, non-compliance, and costly redesigns later. At CMS SciDoc, we provide complete Regulatory Strategy Preparation tailored to your device and target markets. Our service includes: 💠Device classification (MDR, FDA, TGA) 💠Regulatory pathway mapping and requirements 💠Pre-clinical, biocompatibility & clinical evidence planning 💠Technical documentation and testing strategy 💠Submission & approval timelines 💠Risk mitigation and regulatory cost planning Whether you’re a startup or an established manufacturer, we’ll build a clear, compliant and actionable roadmap for your device. Reach out to us today. info@cmsscidoc.com