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pharma business development course
Medical Devices Regulation course





Course Overview


Course FAQ

Course Admission

Medical Device Regulation training provides comprehensive practical training on various aspects of the regulation, registration in different countries and region.

The objective of this course is to impart knowledge and practical understanding about the Medical Devices types, regulatory overview and approval process of Medical Devices.

  • Course Code: KPE-C-025
  • Course Title: KPE’s Advanced Diploma in Medical Device Regulations.
  • Course Type: Distance & e-learning; self paced learning

This online course utilizes interactive learning tools to guide each participant through the steps of medical devices regulations and approval process in details. The course is designed to challenge 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.

The course can be completed at any pace, allowing the user to stop and start at their leisure.

Who should attend?

  • Regulatory Affairs professionals seeking to improve their skills in the regulatory environment
  • Those moving into regulatory affairs from other areas within a medical devices company (Pharmacists, Clinical Trials, Marketing and others)
  • Anyone wishing to update their knowledge on Medical devices industry
  • Anyone who want to know / update about the Medical Devices Business Management / Strategic Plannings

1. Orientation to practical understanding Medical Devices classifications and understanding of the regulatory approval process.

2. Simulation to real life Strategic planning in medical devices management – premarket and post market.

3. Access to industry case studies.

4. Attend Live Lectures of all different chapters / study content.

1 Year 

B.Pharma/D.Pharma/ B.Sc/ Any graduates or those who are in 3rd / final year of those courses, who want to know or upgrade their knowledge about medical devices regulation, can pursue the course.

This course is divided into following modules

1. Overview of medical devices – Introduction, Classifications and Designs.

2. Understanding of the different classes of medical devices in detail.

3. Practical knowledge of medical devices approval process (Pre market requirement)

4. Detailed understanding of the Quality Documentation

5. Handling of the Product Complaint & Product Recall.

6. Handling of Product Withdrawal from market.

7. Marketing, Advertising, Promotion of the medical devices

8. Strategic Business Model for the medical devices companies.

1 Year Advance Diploma Program Syllabus is mentioned below –

US Medical Devices

US Medical Devies Market – Introduction & SWOT Analysis
Definition of Medical Devices
Different Classes of Medical Devices and their working principal
Medical Devices Classification from different regulatory bodies perspective
USFDA – Classification for Medical Devices based on risk
USFDA – CDRH Overview
Medical Devices Regulation in US Introduction to Medical Devices
USFDA regulation
510(k) pre-market notification
Pre-market approval
Details understanding of Pre Market Approval Process with flow chart
510k VS. PMA
Investigational Device Exemption
De Novo Petition – Medical Devices Regulation
Investigational Device Exemption (IDE)
Device Clinical Research
Early/Expanded Access of Medical Devices
Trials of Medical Devices
Humanitarian Device Exemption (HDE)

Labelling Requirement for Medical Devices

Marketing, Advertising and Promotion of Medical Devices

Unapproved use of Medical Devices

EU Regulations

Introduction to EU regulation of Medical Devices
Medical Devices: EU Directives, Classification and Guidance, CE Marking.

QMS for Medical Devices
Quality Management System (QMS) for medical devices company
ISO Certification for Medical Devices company
CE Marking for Medical Devices company

Career in Medical Devices Regulation
Medical Device regulatory professionals responsibility

GMP requirement for medicald devices
c-GMP Requirement for Medical Devices
Packaging standard for Medical Devices
Cleanliness standard
Medical device safety and risk management

Regulation in India
Medical Devices Regulation in India
Registration Process of different class of medical devices in India

Medical Devices Regulation Review and Comparison
Canada, United States, Europe and Australia

Effectiveness/performance of medical devices
Tools and Techniques of performance and effectiveness measurement

Strategic management in medical devices
Medical Devices Life Cycle Management
How to develop medical devices step by step
Patenting medical devices – US, India and other countries
Patent Strategy for medical Devices Industry

Branding basic for medical devices
Brand name
Coding system development
Trademarking medical Devices – practical simulation
Literature development
Technical manual / User development
Difference between literature and technical manual
Working Priniciple Development for medical devices
Evaluation of AD-Claims from perspective of the medical devices regulation

Standard of Medical Devices
Developing standard, following standard

Different classes of medical devices

Dossier preparation training for medical devices

Case Study on Medical Devices

Implantable Medical Devices
Comprehensive understanding of different types of implantable medical devices
Classification basis
Examples based cases – Stents, sutures, orthopaedic implants etc.

Medical devices and technological security issues

Design, prototyping, and product development

Sample marketing plan for medical devices company

Specific issues related to medical devices

Medical Devices Recall – Process

Calibration and validation issues

CAPA – Importance in medical devices

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