Artixio MedTech Training Brochure 2023.pdf

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. 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
[email protected] | M: [phone]
| 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
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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