Advanced Diploma in Medical Devices

Why should I Choose Advanced Diploma in Medical Devices

• Lucrative Career Opportunities
• Impactful Work
• Industry Demand:
• Networking Opportunities
• Technological Innovation
• Interdisciplinary Learning
• Career Advancement
• Continuous Learning
• Industry-Relevant Curriculum
• Personal Fulfillment

Job Opportunities

Upon successful completion of the Certification in Clinical Research Course, students can unlock numerous job opportunities. Some of the potential job roles are outlined below.

• Biomedical Engineer
• Medical Device Designer
• Regulatory Affairs Specialist
• Quality Assurance Manager
• Clinical Research Associate (CRA)
• Product Manager
• Manufacturing Engineer
• Field Service Engineer
• Clinical Engineer
• Healthcare Consultant

Module 1: Introduction to Medical Devices 

• Introduction to Medical devices.
• Introduction to in-vitro devices.
• Introduction to Biologics.
• Introduction to Combination Products

Module 2: Current Good Manufacturing Practices I 

      1. US FDA: Quality system regulation; 21 Code of Federal regulation, part 820  (21 CFR Part 820)

• Includes detailed information about design controls, document controls, identify cation and traceability, production and process controls, process validation, corrective and preventive action.

      2. FDA inspection approach

• Preparing, managing, inspection conclusion, common pitfalls observed.

Module 3: Current Good Manufacturing Practices II

1. European union quality Management system or a Medical device(QMS ISO 13485)

• Compare the requirements between ISO 13485 and ISO 9001
• Interpret the clauses ISO 13485
• Recognize the role and responsibilities of management
• Recognize the relationship between QMS and risk analysis (ISO 14971)
• Compare the requirements between EU QMS (ISO 13485) and US FDA Quality system regulation (21 CFR Part 820)

Module 4: Current Good Manufacturing Practices III (Indian Perspective)         

1. Drugs and cosmetics act, 1940 and drugs and cosmetics rules, 1945)

• Schedule M, Part III (requirements for the manufacture, import and sale of medical devices)
• Role of Clean room in GMP

Module 5: Medical Device Regulatory Affairs I 

International perspective USA – Part -1

1. Overview of Medical device regulation

• Classify your Medical device
• Regulatory Controls
• Medical device user fee and Modernization act
• Device Labelling

     2. How to study and market your device

• Pre – market requirements
• Medical device registration and listing

     3. Pre-market submissions

• Pre-market notification 510 (K)
• Pre-market approval

Module 6: Medical Device Regulatory Affairs I

International perspective USA – Part -2

1. Post market requirements

• Mandatory reporting requirements
• Recalls, correction and removal

     i. Overview Definitions

    ii. Voluntary calls – 21 CFR part 7

    iii. Mandatory device recalls – 21 CFR 810

    iv. Corrections and removals – 21 CFR 806

    v. Regulations

    vi. Federal Register Notices

• Medical Device tracking

      2. Importing and exporting devices

      3. Unique device Identification

Module 7: Medical Device Regulatory Affairs I 

International perspective – EU –  Part -1

1. Medical device directives

• Medical device directive – 93/42/ EEC
• Active Implantable Medical Device Directive – 90/385/ EEC
• Essential requirements checklist
• Clinical evaluation reports
• Risk analysis
• CE Certification

Module 8: Medical Device Regulatory Affairs I 

International perspective – EU –  Part -2

     1. Conformity assessment bodies (CAB) and CE marking (Detailed about class 1, I(s) I(m), IIa, IIb and III Devices)

     2. About notifies bodies and EU authorized representative

     3. Post marketing requirements

Module 9: Medical Device Regulatory Affairs III

Indian Perspective

     1. Indian Market Overview

     2. Medical Device regulatory Structure

     3. Overview regulatory status – Notifies devices

     4. Registration procedure for medical devices (Includes documentation information, Form 40)

     5. Registration validity and time frames

• Medical devices import (Form 10) and Registration
• Medical devices exports and Free sales Certificates

     6. Dossier Contents

• Device Master file
• Site Master file
• Product Labelling
• Shelf life
• Essential principles checklist
• Challenges to regulation

     7. ISO 13458 Regulations

Module 10: Introduction to Risk management to Medical Devices

     1. Documentation requirements

     2. Failure mode effect analysis (FMEA)

     3. Fault Tree Analysis (FTA)

     4. Hazard Analysis and Critical Control Points (HACCP)

Module 11: Biocompatibility Studies

General Idea about Biological evaluation of medical devices – ISO 10993 Part 1- Part 20.
Detailed analysis of common specific tests:

      1. Cytotoxicity

      2. Sensitization

      3. Irritation/ intra- cutaneous toxicity

      4. Acute systemic toxicity

      5. Sub- chronic toxicity

      6. Genotoxicity

      7. Implantation

      8. Hemocompatibility

      9. Chronic toxicity

      10. Carcinogenicity

Module 12: Clinical Trials: Medical Devices

       1. US FDA: Investigational Device Exemption & GCP

• Investigational Device Exemption – 21 CFR Part 54
• Protection of Human Subjects- 21 CFR Part 50
• Institutional Review Board- 21 CFR Part 56
• Financial disclosure by clinical investigators – 21 CFR Part 54
• Design Controls – 21 CFR Part 820 Subpart C

       2. Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice ISO 14155

       3. Difference between ISO 14155 and International Conference on Harmonization – Good
Clinical Practice

       4. Indian perspective- Drugs & Cosmetic Act , Schedule Y

Module 13: In-Vitro Device Regulation

        1. US Perspective

• Classification
• Information about general purpose reagent and analyte specific reagents
• Clinical Laboratory Improvement Amendments of 1988 (CLIA’88)
• Pre-Submission process

         i. Pre-Market Notification 510(K)

         ii. Pre- Market Approval

• Labelling requirements
• Invitro Device Listing
• Invitro Device reporting

       2. EU Perspective

• • Invitro diagnostic Directive 98/79/EC
  • Introduction to In Vitro Diagnostic Devices
  • Introduction to CE Marketing for In vitro Diagnostics Directive
  • Applications of the In vitro Diagnostics Directive
  • Technical files and Design Dossiers for In vitro diagnostic
  • Performance Evaluation and Clinical Evidence for in vitro diagnostics

       3. Indian Perspective 

• IVDs and Diagnostics

Module 14: Overview of Combination Product Regulation

        1. Regulatory Guidelines

        2. Current Good Manufacturing Practice

Module 15: Medical Devices and allied fields: Emerging Area

        1. Medical Device Industry Trends and Challenges

        2. Relevant Medical Device Industry experience sharing : anecdotes from Industry Professionals

About Reva University, Bangalore

Established in 2012, REVA University is a forerunner in delivering technology-based education.

Recognised as one of the Top 50 private universities in India, REVA University, with innovative pedagogy, exemplary infrastructure, and an industry-resilient curriculum that is designed for the future job market, strives to benchmark new milestones in modern education. In less than two decades, the University has grown from a small community of 150 students to a vast institution that is educating and empowering 15,000+ students on campus. University currently offers UG, PG, Ph. D, Diploma and Certificate Programs in Engineering, Architecture, Science & Technology, Commerce, Management Studies, Law, Arts & Humanities, and Performing Arts.

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