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Artixio MedTech Training Brochure 2023.pdf
- 1. Get in Touch Medical Devices In Vitro Diagnostics Global Regulatory Affairs and Quality Excellence in Lifesciences Concept to Market CONSULTING . TRAINING . SERVICES Medical Devices Quality & Compliance Training USA | Germany | UK | Mexico | Brazil | Argentina | UAE | Saudi Arabia | Israel | India | Singapore | Malaysia | Indonesia | Thailand | Hong Kong | Taiwan | Vietnam | Australia | New Zealand Associate Member Awarded Most Preferred Brand Partner for Regulatory & Commercial Support Globally 2021 Artixio Consulting Pvt Ltd ARD Magnum, Rainbow vistas Road, IV Phase, Kukatpally, Hyderabad info@artixio.com | M: +91 8184872200 | www.artixio.com
- 2. www.artixio.com +91 8184872200 Customized, Organization and Product Specific Training designed and delivered to help your team succeed in their compliance and career goals. Training Customized to Your Company WHY CHOOSE ARTIXIO AS YOUR TRAINING PARTNER? Customized, Organization and Product Specific Training designed and delivered to help your team succeed in their compliance and career goals. Real-World Case Studies Experience of teams working with Global Health Authorities right from consulting to post approval maintenance 15+ Years of Experience Successful Approvals and Compliance Achieved in over 40 countries across North America, LATAM, Europe, MENA and APAC Regions. Successful Application in 40+ Countries ·Pre-Training Preparation to Understand Training Needs to Recommend Suitable Solution Pre-Training Consulting Post Training Add-On and Refresher Programs to ensure compliance and continuous learning Post-Training Growth On-site Training with Limited Batch Size for Maximum Participation and Engagement High-Engagement
- 3. www.artixio.com +91 8184872200 BENEFITS OF MEDICAL DEVICES REGULATORY TRAINING FROM ARTIXIO Increased compliance with medical device regulations Reduced risk of product recalls Improved market access Enhanced brand reputation Increased knowledge and skills Networking Opportunities MEDICAL DEVICES REGULATORY TRAINING CUSTOMIZED FOR Product managers Quality engineers Regulatory affairs professionals Sales and marketing professionals Engineers Technicians SCHEDULE AND FORMAT In-Person Training Live Online Training Self-Paced Online
- 4. Product Technical Documents for Regulatory Submissions Regulatory Submissions - US FDA Regulatory Submissions - EU The Medical Device Regulation (MDR) The In Vitro Diagnostic Medical Device Regulation (IVDR) ISO 13485:2016 - General Overview and Training Risk management ISO 14971 Regulatory Submissions - APAC Regulatory Submissions - LATAM Regulatory Submissions - ANZ Quality Management System - Development Quality Management System - Implementation Labelling for Global Regulatory Submissions UDI - EUDAMED Requirements Medical Writing for Regulatory Submissions Clinical Evaluation - Plan and Report Performance Evaluation - Plan and Report Post Marketing Surveillance Requirements Medical Device Standards Training Notified Bodies Experience 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. www.artixio.com +91 8184872200 TRAINING PROGRAMS COVERING ENTIRE LIFECYCLE OF MEDICAL DEVICE
- 5. #1 DISCOVER #2 DESIGN #3 DELIVER #4 DEVELOP www.artixio.com +91 8184872200 ARTIXIO'S 4D APPROACH TO TRAINING Artixio's approach to training begins with understanding your organization's current state. The Current State includes your Organization's business objectives Understanding Products, Key Markets, Departments and Current Quality Management System Assess gaps based on your Team's current state to achieve your business goals Define Future State Based on the expected Future State, Artixio defines the Key learning Outcomes for different audience group within organizations Customize the Training Content suitable to organization, identify training format and methods to measure learning Prepare custom training content modules and deploy in online / offline medium Conduct the Training using preferred delivery format (On-Site / Online / Self- Paced Online Engage audience with Real-World Case Studies to maximize learning and relevance Measure Learning Outcomes at each step to ensure long-term compliance Certify Trainees upon successful completion of the Training Set the Key Learning as Baseline Prepare a Continuous Learning Program over and above the Baseline
- 6. www.artixio.com +91 8184872200 Training Programs Customized Modules backed with Latest Case Studies
- 7. Module Topics 1 Introduction to EU MDR Overview of EU MDR Regulations Applicability to different organizations Applicability to different processes within an organization Organization stakeholders for EU MDR implementation and maintenance 2 Classification of Devices Terminologies and definitions Detailed understanding of Classification rules Conformity Definitions 3 Manufacturers and other stake holders responsibilities Overview of the responsibilities of Manufacturers PRRC - Responsibilities DOC and CE marking GSPR 4 CE Technical File Sections of Technical File Details on content for each section 5 NB and manufacturers NB requirements CA procedures NB procedures Country specification notification 6 UDI and EUDAMED UDI requirements EUDAMED Modules UDI Process and Procedures 7 Clinical Evaluation Clinical Evaluation Plan Clinical Evaluation Report PMCF and other documents 8 Post Market Surveillance Post Market Surveillance Plan Post Market Surveillance Report 9 Challenges in MDR Implementation Common Challenges in MDR Implementation Addressal of challenges - Scenarios Case studies 10 Assessment Course assessment - Multiple Choice Questions and Scenarios based assessment www.artixio.com +91 8184872200 EUROPEAN UNION MEDICAL DEVICE REGULATIONS (EU MDR) TRAINING Program Mode: On-Site Duration: 6-8 Hours