Loading ...

Course / Course Details

Certificate Course in Global Medical Device Regulation

  • Rajashri Ojha image

    By - Rajashri Ojha

  • 0 students
  • 3 Hours
  • (0)

Course Requirements

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.


Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc

Course Description

This courser will cover Definition and Classification, Overview of global medical device industry, Medical device design process, MEDICAL DEVICE REGULATION IN USA, EU, Canada, India, Australia, Japan, China, Middle East, Quality management system, risk management system, clinical and safety testing, MDSAP

Course Curriculum

  • 18 chapters
  • 158 lectures
  • 17 quizzes
  • 3 Hours total length
Toggle all chapters
1 About Us
15 Min

1 Table of Content
15 Min

1 Introduction to Medical Device
15 Min

2 Article/Guidance
15 Min

3 Medical device Introduction PPT
15 Min

4 Medical device Video
1 Min

5 Global Medical Device Market
1 Min

6 MCQs 1 [Quiz]
10 Min

1 Global Medical Device Industry
15 Min

2 Article
15 Min

3 Global medical device PPT 1.1
15 Min

4 global medical device PPT 1.2
15 Min

5 Medical device 123
1 Min

6 Medical Device 2020: Opportunities exceeding challenges
1 Min

7 Global Medical Device overview video 1.1
1 Min

8 Global Medical Device overview video 1.2
1 Min

9 Global Medical Device overview video 1.3
1 Min

10 MCQs 2 [Quiz]
15 Min

1 Design Process
15 Min

2 Article/Guidance
15 Min

3 Device design Process PPT
15 Min

4 design and development part-1 Narkhade
1 Min

5 design and development part-2 Narkhade
1 Min

6 design and development part-3 Narkhade
1 Min

7 design and development part-4 Narkhade
1 Min

8 Design and Development PPT
15 Min

9 MCQs 3 [Quiz]
15 Min

1 Medical Device Regulation in USA
15 Min

2 Article/Guidance - Medical device safety plan
15 Min

3 Article/Guidance - Medical Device label
N/A

4 Article/Guidance - FDA Regulation 1.1
15 Min

5 Article/Guidance - FDA Regulation 1.2
15 Min

6 Medical device regulation in US PPT
15 Min

7 Video
1 Min

8 Medical Device USFDA Video 1.1
1 Min

9 Medical Device USFDA Video 1.2
1 Min

10 Medical Device USFDA Video 1.3
1 Min

11 Medical Device USFDA PPT
15 Min

12 MCQs 4 [Quiz]
13 Min

1 Medical Device Regulation in EU
15 Min

2 Articles 1 : Classification of Medical Device
15 Min

3 Articles 2 : Design Control
15 Min

4 Articles 3 : Regulation
15 Min

5 Medical device regulation in EU PPT
15 Min

6 IVDR Video 1.1
1 Min

7 IVDR Video 1.2
1 Min

8 Medical device in EU
1 Min

9 Medical device usability Highlights of European Regulations and the Latest Standards
1 Min

10 Articles : EUDAMED
15 Min

11 MDR EU part 1 - Video 1.1
1 Min

12 MDR EU part 1 - Video 1.2
1 Min

13 MDR EU part 2 video 1.1
1 Min

14 MDR EU part 2 video 1.2
1 Min

15 MDR EU part 3 video 1.1
1 Min

16 MDR EU part 3 video 1.2
1 Min

17 MDR EU part 4 video 1.1
1 Min

18 MDR EU part 4 video 1.2
1 Min

19 Medical Device Regulation - EU-Video 1.1
1 Min

20 Medical Device Regulation - EU-Video 1.2
1 Min

21 Medical Device Regulation -EU-Video 1.3
1 Min

22 Medical Device Regulation - EU-Video 1.4
1 Min

23 Medical Device Regulation -EU-Video 1.5
1 Min

24 Medical Device Regulation Lecture PPT
15 Min

25 MCQs 5 [Quiz]
15 Min

1 Medical Regulation in Canada
15 Min

2 Article
15 Min

3 Canada Regulation PPT
15 Min

4 How to Search for Medical Device Class and License Medical Devices in Canada Video
1 Min

5 Medical Device Regulation Video
1 Min

6 MCQs 6 [Quiz]
15 Min

1 Medical Device Regulation in Australia
15 Min

2 Article
15 Min

3 Australia Regulation PPT
15 Min

4 Video 1.1
1 Min

5 Video 1.2
1 Min

6 MCQs 7 [Quiz]
12 Min

1 Medical Device Regulation in Japan
15 Min

2 Article
15 Min

3 PPT
15 Min

4 Medical Device Regulations and Utilization of International Standards in Japan
15 Min

5 Medical Device Regulation in Japan Video 1.1
1 Min

6 Medical Device Regulation in Japan Video 1.2
1 Min

7 Medical Device Regulation in Japan Video 1.3
1 Min

8 MCQs 8 [Quiz]
14 Min

1 Medical Device Regulation in China
15 Min

2 Article
15 Min

3 PPT
15 Min

4 Medical Device In China - Video 1.1
1 Min

5 Medical Device In China - Video 1.2
1 Min

6 MCQs 9 [Quiz]
15 Min

1 Medical Device Regulation in Middle East Region
15 Min

2 Article
15 Min

3 MCQs 10 [Quiz]
15 Min

1 Medical Device Regulation in India
15 Min

2 Medical Device Rule 2017
15 Min

3 Medical Device Rule guidance 1.1
15 Min

4 Medical Device Rule guidance 1.2
15 Min

5 Medical Device Rule guidance 1.3
15 Min

6 Medical Device Rule guidance 1.4
15 Min

7 Medical Device Rule guidance 1.5
15 Min

8 MDR video 1.1
1 Min

9 MDR video 1.2
1 Min

10 Sugam Portal Submission 1.1
1 Min

11 Sugam Portal Submission 1.2
1 Min

12 Medical Device Rule 2017 Video 1.1
1 Min

13 Medical Device Rule 2017 Video 1.2
1 Min

14 Medical Device Rule 2017 Video 1.3
1 Min

15 Medical Device Rule 2017 Video 1.4
1 Min

16 Medical Device Rule PPT
15 Min

17 Sugam Portal Submission
15 Min

18 BIS Submission
15 Min

19 BIS Submission Video 1.1
1 Min

20 BIS Submission Video 1.2
1 Min

21 MCQs 11 [Quiz]
15 Min

1 Quality management System for Medical Device
15 Min

2 ISO 13485-2016 PPT
15 Min

3 Article/Guidance
15 Min

4 QMS part 1 - videos 1.1
1 Min

5 QMS part 1 - videos 1.2
1 Min

6 QMS- Part 2 - video 1.1
1 Min

7 QMS- Part 2 - video 1.2
1 Min

8 QMS- Part 3 - video 1.1
1 Min

9 QMS- Part 3 - video 1.2
1 Min

10 How to verify ISO 13485 certificate
1 Min

11 5 difference between product certification and management system certification
1 Min

12 MCQs 12 [Quiz]
N/A

1 Risk Management for Medical Device
15 Min

2 ISO 14971 : 2019 PPT
15 Min

3 Change to ISO Video 1.1
1 Min

4 Change to ISO Video 1.2
1 Min

5 Risk Management Video 1.1
1 Min

6 Risk Management Video 1.2
1 Min

7 MCQs 13 [Quiz]
14 Min

1 Medical Device Single Audit Program
15 Min

2 Guidance
15 Min

3 PPT
15 Min

4 Stepping into MDSAP Video
1 Min

5 MDSAP Video part 1
1 Min

6 MDSAP Video part 2
1 Min

7 MDSAP Video part 4
1 Min

8 MDSAP Video part 3
1 Min

9 MDSAP Video part 5
1 Min

10 MDSAP Video part 6
1 Min

11 MDSAP Video part 7
1 Min

12 MDSAP Video part 8
1 Min

13 MDSAP Video part 9
1 Min

14 MDSAP Video part 10
1 Min

15 MCQs 14 [Quiz]
15 Min

1 Clinical Testing and Safety of Medical Device
15 Min

2 guidance
15 Min

3 Clinical investigation Part 1 -Video 1.1
1 Min

4 Clinical investigation Part 1 -Video 1.2
1 Min

5 clinical investigation part2 - video 1.1
1 Min

6 clinical investigation part2 - video 1.2
1 Min

7 Clinical Evidence Requirement PPT
15 Min

8 MCQ 15 [Quiz]
14 Min

1 MCQs [Quiz]
1 Hour 20 Min

2 Final Exam Global MDR [Quiz]
1 Hour 40 Min

Instructor

Rajashri Ojha

0 Rating
0 Reviews
11 Students
141 Courses

Course Full Rating

0

Course Rating
(0)
(0)
(0)
(0)
(0)

No Review found

Sign In or Sign Up as student to post a review

Student Feedback

Course you might like

Short Courses
Biologics/Biosimilar Submission as per US and EU
0 (0 Rating)
0 Students
Introduction in BiologicsHistory of BiologicsAdvancing Biomedical ScienceComparison of development and characteristics b...
7,499.00 ₹ 9,000.00 ₹
Regular Courses
Medical Devices Regulation – MDD TO MDR Implementation
0 (0 Rating)
0 Students
This module will cover Difference and similarities between MDD and MDR, MDR Transition period, key aspect of new regulat...
3,499.00 ₹ 4,200.00 ₹

You must be enrolled to ask a question

Students also bought

GLOBAL Regulatory Affairs (GRA)
Regular Courses
  • 355 Lectures
  • 10 Min
  • 0 (0 Rating)
  • 1 Students
  • 24,999.00 ₹
  • 30,000.00 ₹
  • 0 (0 Rating)
  • 1 Students
  • 7,499.00 ₹
  • 9,000.00 ₹
Test Webinar 3
Short Courses
  • 0 Lectures
  • N/A
  • 0 (0 Rating)
  • 1 Students
  • Free
new webinaar
Short Courses
  • 0 Lectures
  • N/A
  • 0 (0 Rating)
  • 1 Students
  • Free

24,999.00 ₹

30,000.00 ₹

Add To Cart Buy Now

  • Duration 3 Hours

  • Lectures 158 lessons

  • Enrolled 0 students

  • Category: Medical Device

  • 17 Quizzes

  • Language: English

  • Skill Level Regular Courses

  • Certificate of Completion

  • 7 Days Access

Remove Coupon
Coupon Applied!

More Courses by Author

Discover Additional Learning Opportunities

View All
Short Courses
Biologics/Biosimilar Submission as per US and EU
0 (0 Ratings)
0 Students
Introduction in BiologicsHistory of BiologicsAdvancing Biomedical ScienceComparison of development a...
7,499.00 ₹ 9,000.00 ₹
Short Courses
MDD to MDR Implementation
0 (0 Ratings)
0 Students
This module will cover Difference and similarities between MDD and MDR, MDR Transition period, key a...
7,499.00 ₹ 9,000.00 ₹
Short Courses
Effective CMC Writing and Review Skill
0 (0 Ratings)
0 Students
This course will cover Basics of CMCs, effective technical CMC Writing skills, CTD Module 3-Quality...
7,499.00 ₹ 9,000.00 ₹
Short Courses
Drug Regulatory System In Us
0 (0 Ratings)
1 Students
This course covers History of FDA and Related Regulatory Agencies, FDA & CDER – Organization and res...
3,500.00 ₹ 4,200.00 ₹
Short Courses
Drug Regulation in Europe
0 (0 Ratings)
0 Students
This course will cover Pharmaceuticals in the European Union, History of Drug Regulation in European...
3,500.00 ₹ 4,200.00 ₹
Short Courses
ICH Q2 Analytical Validation
0 (0 Ratings)
0 Students
This module will cover analytical method validation procedure and its importance, ICH Q 2 guidance
1,499.00 ₹ 1,800.00 ₹

Shopping Cart

Loading...