InstructorRoyed Training
TypeOnline Course
Student Enrolled16
Price$650
Buy NowBook Now

This course is designed exclusively with objective to impart Induction Training for Regulatory Affairs.

Core Learning Areas

  • Medical Devices Development to Commercialization – R&D Process, New Device Development, NPD process briefing. 
  • Device Clinical Trials: Clinical trials, Fundamental understanding on clinical trial terminologies, Various strategic planning for clinical development. Handling of patent and exclusivity. 
  • Medical Devices Regulation: Medical Devices classification | Premarket approval process | 510k | 510k vs. PMA | PMA post submission – CRL | Labeling requirements | Investigational Device Exemption | Early / Expanded access | Q-sub | Medical Devices Post approval variation | Expedited Review | Expiration dates | Device master file | Unapproved use for Medical Devices | FDA 513g | DeNovo Petition – Types, Review Process | Humanitarian Device Exemption (HDE) | Combination Products Classification, regulation, strategic planning.
  • Medical Devices Quality Management System (QMS) | Quality Risk Management Training | ISO 14971. 
  • Advanced c-GMP training for med tech plant.
  • Certification required for a medical devices plant – ISO 13485, CE and other various certifications required for Med tech plants.
  • CE Certification Training.
  • EU MDR training.
  • Authorization Pathways for marketing authorization of the medical devices in various business regions – US, EU, LATAM, GCC, Middle East, GCC, Latam, India, Africa, Japan, China and ROW.
  • Portfolio Management Training| Strategic Planning Process | Knowledge Area of Business Development | Lead targeting | Licensing term sheets Portfolio Management Process | Portfolio Characteristics | Portfolio Analysis | Balancing the Portfolion
  • Advance training on technical dossier preparation.
  • Medical devices labeling development training.

Methodology: Login with your user id and password and access the course step by step. Course will be available on your existing user account. In case you lost or do not remember the password kindly reset here

Course duration: 90 Days from the date of activation of the course.

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Corporate Training: Specialized designed for the employees of SynerG Biopharma.

Usage Restricted to SynerG Biopharma Employees Only !

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Section 1US MEDICAL DEVICES | Development to Commercialization Cycle
Lecture 1Overall Understanding of US Medical Devices
Lecture 2Definition of Medical Devices
Lecture 3Classification of Medical Devices
Lecture 4Medical Devices Classification : Work File 
Lecture 5Medical Device Development to Commercialization Process | Understanding Key Stages and respective stage level activities | Important MDR terminologies
Lecture 6How to establish the classification of the medical device 
Lecture 7FDA Product Code Database : Hands on Training
Lecture 8513(g) Application : Request, User Fees, Review Process
Section 2510K PRE-MARKET NOTIFICATION
Lecture 9Overall Understanding
Lecture 10Predicate Devices | Substantially Equivalent (SE)
Lecture 11Understanding on 510k | Types of the 510k | Timeline | Difference with PMA
Lecture 12FDA decision making process for different classes of 510k applications
Lecture 13Review Test
Section 3PREMARKET APPROVAL (PMA) APPLICATION
Lecture 14Premarket approval (PMA) application
Lecture 15Differences between 510k VS. PMA
Lecture 16PMA Data Requirements : Standard Data | GCP | Clinical | Non-clinical Dataset | Other Data
Lecture 17Advanced Understanding on Data Requirements for A Premarket Approval (PMA) application 
Lecture 18PMA Post Submission Actions
Lecture 19PMA Post Submission - Management of CRL - Timeline and Strategic Planning
Lecture 20Investigational Device Exemption | Device Clinical Research | Early/Expanded Access of Medical Devices | Q-Sub | IDE Submission Requirements
Lecture 21Medical Devices Development to Commercialization Stages | Devices Clinical Trial | Stages | Critical differences with pharmaceutical clinical trial
Lecture 22Medical Devices Post Approval Variations | PMA supplement | PMA amendments | Variation Management Strategic Planning
Lecture 23Labeling Requirement for Medical Devices 
Lecture 24Expiration Dates
Lecture 25Device Master Files
Lecture 26Unapproved use of Medical Devices
Lecture 27Marketing, Advertising and Promotion of Medical Devices
Lecture 28Significance of Submitting a FDA 513(g)
Lecture 29DeNovo Petition - Types of DeNovo Pathways | Details of Review Process | Strategic Planning
Lecture 30Humanitarian Device Exemption (HDE)
Lecture 31Download Template of Technical Dossier
Section 4COMBINATION PRODUCTS
Lecture 32Definition of combination products
Lecture 33Combination Product RFD Designation Process | Importance | Timeline | Outcome Management
Lecture 34Combination Products Pre-market Approval Process | Lead centers | Concept of Primary Mode of Action | Strategic Submission Pathways
Section 5Labeling Requirements for Medical Devices
Lecture 35Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents 
Lecture 36Instruction for Use (IFU)
Lecture 37UDI | Different Component | How to design  
Lecture 38EU MDR Compliance Process 
Section 6EU REGULATION FOR MEDICAL DEVICES
Lecture 39EU MDR Classification
Lecture 40EU MDD | EU MDR | Articles | Rules | Pages | Annex | Key Changes in EU MDR
Lecture 41EU MDR  | Annexes | Key notes
Lecture 42EU Medical Device Regulation System | MDR | IVDR | UDI | EUDAMED | Requirements for manufacturer | Importer | Distributor | Declaration of Conformity (DoC)
Lecture 43EU MDR Guideline | EU MDR - Annexes 
Lecture 44EU MDR Conformity Assessment procedure | Assessment of various classes and types of the devices | Key points to consider | Conformity assessment master chart 
Lecture 45EU MDR Authorized Representatives | Mandate | Role and Responsibilities
Lecture 46EU MDR Compliance Process 
Lecture 47Thumb Rules of Classification as per EU MDR Guideline | Invasive | Non-invasive | Active | Special Devices 
Lecture 48Review : DDF DHF DMR MDF DHR 
Section 7QMS, Documentation and Dossier Preparation
Lecture 49Medical Device Technical File
Lecture 50Medical Device Dossier Preparation | Section Wise Dossier Preparation | Key Requirements regarding dossier | Points to note regarding each section of the dossier 
Lecture 51Quality Management System (QMS) for medical devices company 
Lecture 52Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Lecture 53Comparing Medical Device Regulations | 510k Submission | Technical File | Design History File | Design Master File 
Lecture 54Medical Device Essential Principle Checklist | Documentation |  Open file
Lecture 55Implant Card | Regulatory Importance | Content | How to design 
Section 8MEDICAL DEVICES REGULATION IN INDIA
Lecture 56Medical Devices Regulation in India | Overall understanding
Lecture 57Regulatory Landscape in India
Lecture 58Classification of the Medical Devices in India | Strategic Planning for the Submission 
Lecture 59Notified and Non-notified Device | Submission Strategic Planning 
Lecture 60Medical Devices Classification in India - Work Doc
Lecture 61Notified Devices | Registration Process
Lecture 62Medical Device Submission Strategic Pathways | Step by step Process 
Lecture 63Medical Device Forms | Purposes
Lecture 64Non Regulatory Medical Devices
Lecture 65Medical Device Voluntary Registration | Documentation | Process
Lecture 66List of Notified Devices | Newly Notified Devices | Significance
Lecture 67List of Notified Bodies with CDSCO
Section 9CE MARKING
Lecture 68Introduction to CE Marking
Lecture 69CE- Self Certification
Lecture 70General principles of the CE marking
Lecture 71Manufacturer Responsibilities
Lecture 72Third Party Medical Device Manufacturing & CE Marking
Lecture 73Classifying Medical Devices Based on the Type of Manufacturing Operation
Lecture 74Understanding Terminologies - OBL/PBL/PLM/OEM/OES
Lecture 75Step By Step CE Marking Process
Lecture 76Case Study
Section 10ISO 13485:2016 : IMPLEMENTATION IN MEDICAL DEVICE ORGANIZATION
Lecture 77Introduction to ISO 13485:2016
Lecture 78ISO 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
Lecture 81South Africa Medical Device Regulation
Lecture 82Egypt Medical Device Regulation
Lecture 83Kenya Medical Device Regulation
Lecture 84Nigeria Medical Device Regulation
Section 14Medical Devices Regulation in Canada
Section 15Final Examination and Certificate Generation