Course Code: KPE-C-018
Course Title: KPE’s Certificate Course in Medical Device Regulations.
Course Objective: 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.
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 Planning
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.
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.
Phase 1: US Medical Devices
US Medical Devies Market – Introduction & SWOT Analysis
Definition of Medical Devices
Different Classes of Medical Devices and their working principal
USFDA – Classification for Medical Devices based on risk
USFDA – CDRH Overview
Medical Devices Regulation in US Introduction to Medical Devices
510(k) pre-market notification
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)
Section 6: Labeling Requirement for Medical Devices
Section 7: Marketing, Advertising and Promotion of Medical Devices
Section 8: Unapproved use of Medical Devices
Phase 2 : Review Assessment Tests on USFDA Medical Devices
Phase 3: EU Regulations
Section 1 : EU regulation of Medical Devices Session 1
Medical Devices: EU Directives, Classification and Guidance, CE Marking.
Section 2: Quality Management System (QMS) for medical devices company
ISO Certification for Medical Devices company
CE Marking for Medical Devices company
Medical Device regulatory professionals responsibility
Phase 4: c-GMP Requirement for Medical Devices
Phase 5: Medical Devices Regulation in India
Phase 6: Medical Devices Regulation Review – Canada, United States, Europe and Australia
Phase 7: Medical Devices Classification from different regulatory bodies perspective
Phase 8: Packaging standard for Medical Devices
Phase 9: Medical device safety and risk management
Phase 10: Effectiveness/performance of medical devices
Phase 11: Medical Devices Life Cycle Management
Phase 12: Standard of Medical Devices
Phase 13: Case Study on Medical Devices