InstructorRoyed Training
TypeOnline Course
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medical device global business course

Introduction

Learning areas

Who should attend

Course Type

Duration

Eligibility

Certification

Course Deliverable

Features

Related Courses

medical device executive program

Medical Device Global Business training course provides hands-on training of medical devices discovery to the commercialization process.
medical device global business training

This Executive PG certification course in Medical Devices covers medical devices strategic management and planning process. Hence, this course will demonstrate medical devices business skills  and concepts. Most importantly, The course provides cased based learning. As a result, it helps participants to understand the medical device discovery to commercialization process. Moreover, cutting edge simulations help participants to understand medical device business development tools and techniques. 

Online Self Paced Learning

In addition, this medical devices regulatory affairs course challenges students and Professionals to apply what they have learned through the use of interactive exercises, reflection questions, and a final assessment at the end of the course.

The course can be completed at any place. So, it allows the user to stop and start at their leisure. 

Moreover, user can access the course at own pace. It allows the user to stop and start at their leisure. 

Course Code: RYD-083

Course Title: Executive PG Certification in Medical Devices Global Business (EPMDGB)

Key learning areas of Medical Devices Global Business Course

This medical device training includes training in following core domains:

  • Medical Device discovery, development to commercialization.
  • Advertising, promotion and marketing management process for medical device brand.
  • Medical Device Brand Management.
  • Region specific medical device business development.
  • Medical Devices Licensing.
  • Advanced Digital Marketing for medical device company.

Who should attend?

  • This course is ideal for Medical Devices Strategic Management and Business Development Professionals who are seeking to improve their skills in the medical devices global business environment.
  • The course covers the medical device brand management principles in depth. Therefore, it will be ideal medical device training for Brand Managers.
  • Moreover, this medical device course is ideal for executives who are entering into medical device industry from other domain, like pharmaceutical, Biopharmaceutical, FMCG, Food, Cosmetics etc.
  • Similarly, this course is useful to those who wishes update their knowledge on medical device marketing authorization process in various across different regulatory bodies.
  • Above all, this course suits to medical device regulatory affairs professionals, who want to move into medical device Business Development and Strategic Management Department.

Online distance learning course. Course can be accessed online across anywhere 24×7.

1 Year from the date of initiation of the course. But, one can complete the course anytime within 1 year period. So, if anyone want to complete within 3 or 4 month, he or she can do it effectively.

Graduation in any discipline.

Certificate will be provided at the end of the successful completion of the course

  1. Attend the course 24×7 by login to your dashboard. Hence, one can attend lectures, simulation, self assessment tests and final certification examination.
  2. You will also be eligible to receive the course study modules, which you can download by login to your course page.

Course Features

This medical device training course utilizes 24×7 interactive learning tools to guide each participant through medical device business operation management. Therefore, the course challenges students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.

Important Learning Features: 

  • Online 24×7 access from anywhere. Hence, one can learn at your convenience.
  • Hence, the course provides timing flexibility. In other words, one can attend the lecture sessions at your own convenient time.
  • Above all, course provides simulation for real life working. Hence, it helps user to apply the decision making skill in real life scenarios.

Course Coverage Area

  • Advance practical training in premarket approval process.
  • Advance training on technical dossier preparation.
  • Detailed training on ISO 13485 and CE certification process.
  • Training on Medical device technical dossier preparation.
  • Medical Devices marketing and brand management skill training.
  • Practical training on artwork development.
  • Medical Device portfolio management and planning.
  • Understanding on medical device export documentation.
  • Medical Device business development and licensing training.
  • Advance understanding on medical device business development requirements across different regions, e.g. US, EU, Canada, GCC, ASEAN, LATAM, China, India etc.
  • Financial management for medical device company.
  • Brand valuation.
  • Medical devices digital marketing training.

Related Courses

List of Medical Devices Course –

Medical Devices Training Courses


Course Code

Course

Duration

RYD-083 (Executive Program)

Medical Device Global Business

1 Year

RYD-077

Drug Biologic Medical Device Regulatory Affairs

1 Year

RYD-006

Medical Devices Regulation

1 Year

RYD-082

US Medical Device Regulation

1 month

RYD-035

CE Certification in Medical Devices

3 Days
Section 1US MEDICAL DEVICES
Lecture 1Overall Understanding of US Medical Devices
Lecture 2Definition of Medical Devices
Lecture 3Classification of Medical Devices
Lecture 4Examples of Medical Devices
Lecture 5Medical Device Development to Commercialization Process | Understanding Key Stages and respective stage level activities | Important MDR terminologies
Section 2510K PRE-MARKET NOTIFICATION
Lecture 6Overall Understanding
Lecture 7Predicate Devices | Substantially Equivalent (SE)
Lecture 8Understanding on 510k | Types of the 510k | Timeline | Difference with PMA
Lecture 9FDA decision making process for different classes of 510k applications
Lecture 10Review Test
Section 3PREMARKET APPROVAL (PMA) APPLICATION
Lecture 11Premarket approval (PMA) application
Lecture 12Differences between 510k VS. PMA
Lecture 13Data Requirements for A Premarket Approval (PMA) application
Lecture 14Data Requirements for A Premarket Approval (PMA) application
Lecture 15PMA Post Submission - Management of CRL - Timeline and Strategic Planning
Lecture 16Labeling Requirement for Medical Devices
Lecture 17Investigational Device Exemption | Device Clinical Research | Early/Expanded Access of Medical Devices | Q-Sub | IDE Submission Requirements
Lecture 18Medical Devices Development to Commercialization Stages | Devices Clinical Trial | Stages | Critical differences with pharmaceutical clinical trial
Lecture 19Medical Devices Post Approval Variations | PMA supplement | PMA amendments | Variation Management Strategic Planning
Lecture 20Expedited Review of PMA application
Lecture 21Expiration Dates
Lecture 22Device Master Files
Lecture 23Unapproved use of Medical Devices
Lecture 24Marketing, Advertising and Promotion of Medical Devices
Lecture 25Significance of Submitting a FDA 513(g)
Lecture 26DeNovo Petition - Types of DeNovo Pathways | Details of Review Process | Strategic Planning
Lecture 27Humanitarian Device Exemption (HDE)
Section 4COMBINATION PRODUCTS
Lecture 28Definition of combination products
Lecture 29Examples of Combination Products
Lecture 30Premarket Review and Postmarket Regulation of Combination Products
Lecture 31Drug Led Combination Product Pathway - R&D Process & drug discovery pathway 
Lecture 32Drug Led Combination Product Pathway - NDA
Lecture 33Drug Led Combination Product Pathway - Abbreviated New Drug Application (ANDA) 
Lecture 34Drug Led Combination Product Pathway - Biological Licensing Application (BLA) 
Lecture 35Drug Led Combination Product Pathway  -  Abbreviated Biosimilar Application - 351(k)
Section 5MEDICAL DEVICES REGULATION IN CANADA
Section 6EU REGULATION FOR MEDICAL DEVICES
Lecture 37EU MDR Classification
Lecture 38EU MDD | EU MDR | Articles | Rules | Pages | Annex | Key Changes in EU MDR
Lecture 39EU MDR  | Annexes | Key notes
Lecture 40EU Medical Device Regulation System | MDR | IVDR | UDI | EUDAMED | Requirements for manufacturer | Importer | Distributor | Declaration of Conformity (DoC)
Lecture 41EU MDR Guideline | EU MDR - Annexes 
Lecture 42EU MDR Conformity Assessment procedure | Assessment of various classes and types of the devices | Key points to consider | Conformity assessment master chart 
Lecture 43Medical Device Technical File
Lecture 44Medical Device Dossier Preparation | Section Wise Dossier Preparation | Key Requirements regarding dossier | Points to note regarding each section of the dossier 
Lecture 45Quality Management System (QMS) for medical devices company 
Lecture 46Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Lecture 47Comparing Medical Device Regulations | 510k Submission | Technical File | Design History File | Design Master File 
Lecture 48Medical Device Essential Principle Checklist | Documentation |  Open file
Lecture 49Implant Card | Regulatory Importance | Content | How to design 
Section 7483 Observations, Warning Letter, Data Integrity
Lecture 50Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 51Documentation | Good Documentation Practices
Lecture 52Training on Handling and Management of Data Integrity issues in Pharmaceutical, Biopharmaceutical and Medical Devices Industry
Section 8MEDICAL DEVICES REGULATION IN INDIA
Section 9TECHNICAL DOSSIER
Lecture 54Introduction
Lecture 55Components of technical documentations
Lecture 56Technical Dossier - Information Required
Section 10ISO 13485:2016 : IMPLEMENTATION IN MEDICAL DEVICE ORGANIZATION
Lecture 57Introduction to ISO 13485:2016
Lecture 58ISO 13485:2016 Audit Checklist
Section 11Medical Devices Regulation in Asian Countries - UAE, Bangladesh, Bahrain, Indonesia, China, India, Iran, Jordan, Japan, Kuwait, Korea, Lebanon, Malaysia, Pakistan, Philippines, Saudi Arabia, Singapore, Vietnam
Section 12Medical Devices Regulation in Latam Countries:  Argentina, Brazil, Colombia, Chile, Mexico, Paraguay, Uruguay
Section 13Medical Devices Regulation in African Countries: Algeria, Kenya, Nigeria, South Africa, Egypt
Section 14Medical Device Branding and Marketing
Lecture 62Product Life cycle for Medical Device
Lecture 63Advanced Strategic Planning in Medical Devices Product Life cycle Management
Lecture 64Segmentation, Targeting and Positioning of Medical Devices
Lecture 65Pricing of Medical Devices
Lecture 66Promotion in medical device Industry : Communication Model, Effective promotional communication, Push Vs. Pull Strategy and Buying Decision Process
Lecture 67Method of Promotional Budgeting
Lecture 68Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?
Lecture 69Advertising - Introduction | Objective | Types of Advertising 
Lecture 70ATL, BTL & TTL Advertising
Lecture 71Advertising Agency - Understanding on various types of advertising agency
Lecture 72Selection of Advertising Agency
Lecture 73What is creative Briefing? How to Prepare !
Lecture 74Creative Briefing - Practical Simulation
Lecture 75Request for Proposal | Concepts in advertising
Lecture 76Advertising Message Strategy Development and Evaluation
Lecture 77Creative Approach and Styles
Lecture 78Steps of Development of Creatives
Lecture 79Advertisement Copy Development
Lecture 80How to prepare Ad Campaign Step By Step
Lecture 81New Product Development | Product Levels | Concept of Augmented Product
Lecture 82Market Research Process | Primary Research | Secondary Research | How Market Research carried out | CMI Team
Lecture 83Brand Logo Development : Introduction | Design Basics | Understanding of various components
Lecture 84Brand Name : Fundamental understanding on Brand Name Selection
Lecture 85Logo colour theme | Colour system | Colour coding | Significance of colour
Lecture 86How to design an excellent brand logo : Tricks of the trade
Lecture 87Trademark Searching Process | Hands on Practical Training
Lecture 88Brand Tagline or Punchline for Medical Device
Lecture 89Tagline - Development, Finalization and Protection
Lecture 90Medical Devices Brand Plan Development : Step by step preparation of the brand plan Development
Lecture 91Practical Training in visual aid designing  | Step By Step Visual Aid Preparation | Creative Designing | Guideline on Proofing | USPs to differentiate the visual aid 
Lecture 92Visual Aid Printing  | Establishing Visual Aid Printing Specs for effective management of the vendors 
Lecture 93Guideline on visual aid development
Lecture 94Interactive Visual Aid | E-detailing | Remote Detailing | Analysis of Animated Video based e-detailing visual aids 
Lecture 95Artwork Development Process by Product Management Team / Brand Management Team 
Section 15Medical Device Export Documentation
Lecture 96Introduction to Medical Device Export
Lecture 97Introduction of Export Documentation | Understanding of important terminologies
Lecture 98Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 99Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 100Commercial Invoice | Importance | Differences with Proforma Invoice 
Lecture 101Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 102Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 103Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 104LC Discounting | How it works | How to calculate the LC discounting
Lecture 105Packing List | Importance | Things to include in packing list
Lecture 106Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 107Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 108Pre-shipment certificates
Lecture 109Preshipment Inspection Certificate 
Section 16Medical Device Business Development and Licensing
Lecture 110Business Development Job Functionality | Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets
Lecture 111Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolio | BD and Strategic Planning Department 
Lecture 112Identifying the corporate Need of business development | Objective – Strategy - Tactics | Portfolio constraints | SWOT | Numerical SWOT
Lecture 113Profiling and Searching | Objectives | Search Database | Creating Opportunity Anatomy for deal analysis | Mind Mapping | Searching Tools and Techniques - Web Search | Conference | Confidentaility - CDA | MTA
Lecture 114Modelling and Deal Valuation - Top Down Model | Epidemiology data method | Complex Model | Forecasting | Heuristic or ‘prophesy’ method | Different value perspectives | Deal Structuring Structuring the deal
Lecture 115Market Size Determination - Market Share | Relative Market Share | Total Vs. Actual Vs. Penetrated Market
Lecture 116Forecasting : Tools and Techniques
Lecture 117Types of Strategic Alliances: Unilateral technology licensing | Cross technology licensing | R&D contracts | R&D collaborations | Minority-equity-based R&D alliances | JV | Manufacturing and marketing agreements 
Lecture 118Licensing and Technology Transfer
Lecture 119Licensing - Advance Learning 
Lecture 120Distribution Licensing | Geography | Indication Splitting | Execlusive and Non-Exclusive Licensing | Sub Licenses
Lecture 121Negotiation Skill Training
Lecture 122Licensing Agreement : Confidentiality Agreement | MTA | A deed of Assignment | Exclusive | Non-Exclusive License | Sole License | Components - Terms - Duration - Key Considerations
Lecture 123Step By Step Implementation of Licensing Deal
Lecture 124Due Diligence Activities in Licensing
Section 17Financials of deal management
Lecture 125Training on Basic Finance  |  Understanding Financial Statement | Income Statement | Balance Sheet | Cash Flow Statement
Lecture 126Training on Valuation Methods: DCF | rNPV | Sunk Cost Method | Comparables | Sum of Parts | Deterministic Vs. Probabilistic rNPV |  Peak Sales - Max-Min Approach
Lecture 127Valuation Methods: EBITDA method of valuation | Enterprise Value and Enterprise Multiple Calculation
Lecture 128Business Development Simulation and Decision Making | Early Stage VS. Late Stage Valuation Methodology | Stair Step Model
Section 18Digital Marketing for Medical Devices
Lecture 129Introduction to Digital Marketing | Different Types of Media | Paid media | Earned Media | Owned Media | E-business | E-commerce | E-commerce architecture | E-communication Tools | Strategy and KPIs 
Lecture 130Inbound and Outbound Marketing
Lecture 131Digital Media Marketing Macro-Environment Analysis | Mapping of online market place | Internet marketing conversion process | Conversion Process Digital VS. Traditional | Publisher revenue model | Affiliate revenue model
Lecture 132Digital Media Marketing Micro - Environment Analysis | Web server | Web browser | http vs. https - Significance and hands on understanding | Privacy and ethical issues in internet marketing
Lecture 133Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement
Lecture 134Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism
Lecture 135Campaign planning for digital media | Goal setting | Tracking | Campaign insight | Segmentation and targeting | Message Development | Media Mix Selection | Media scheduling | Practical understanding to campaign performance matrics | CPC | CPA | PPC | ROI | CPS
Lecture 136Web Analytics - Tool and Implementation 
Lecture 137Web Host - Check the hosting details 
Lecture 138Page Speed- importance and practical understanding | Check the web speed 
Lecture 139Search Engine Optimization | Search Engine Marketing | Social Media Marketing
Lecture 140Keyword | Keyword Planning for SEO and SEM | Keyword Planner
Lecture 141Mobile Responsive | Tracking the Site 
Lecture 142Google Ad - Practical Training on Campaign Development and Execution
Lecture 143Brand Portal Development
Lecture 144Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release