Medical Device Regulatory Affairs

InstructorRoyed Training

TypeOnline Course

Student Enrolled16

Price$650

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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 41EU MDR | Annexes | Key notes

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