Loading ...

Course / Course Details

MDD to MDR Implementation

  • 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 module will cover Difference and similarities between MDD and MDR, MDR Transition period, key aspect of new regulations, new regulatory process

Course Curriculum

  • 4 chapters
  • 33 lectures
  • 0 quizzes
  • 3 Hours total length
Toggle all chapters
1 Medical Device Rule 2017 video 1.1
1 Min

2 Medical Device Rule 2017 video 1.2
1 Min

3 Medical Device Rule 2017 guidance
15 Min

4 Sugam portal submission video 1.1
1 Min

5 Sugam portal submission video 1.2
1 Min

6 BIS Submission video 1.1
1 Min

7 BIS Submission video 1.2
1 Min

1 MDR EU video 1.1
1 Min

2 MDR EU video 1.2
1 Min

3 MDR EU video 1.3
1 Min

4 MDR -EU video 1.1
1 Min

5 MDR -EU video 1.2
1 Min

6 MDR -EU video 1.3
1 Min

7 MDR -EU video 1.4
1 Min

8 MDR -EU video 1.5
1 Min

1 USFDA video 1.1
1 Min

2 USFDA video 1.2
1 Min

3 USFDA video 1.3
1 Min

1 Course Content and Guidelines PPT 1
15 Min

2 Course Content and Guidelines PPT 2
15 Min

3 Course Content and Guidelines PPT 3
15 Min

4 Course Content and Guidelines PPT 4
15 Min

5 Course Content and Guidelines PPT 5
15 Min

6 Course Content and Guidelines PPT 6
15 Min

7 Course Content and Guidelines PPT 7
15 Min

8 Indian MDR 2017
15 Min

9 PMS
15 Min

10 MDD to MDR Key Changes
15 Min

11 Medical device safety plan
15 Min

12 Post Market Clinical Follow up studies
15 Min

13 GHTF-Essential principle safety performance
15 Min

14 GHTF summary technical documentation ivd safety conformity
15 Min

15 Guidance on the Declaration of Conformity
15 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
Certificate Course in Global Medical Device Regulation
0 (0 Rating)
0 Students
This courser will cover Definition and Classification, Overview of global medical device industry, Medical device design...
24,999.00 ₹ 30,000.00 ₹

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

7,499.00 ₹

9,000.00 ₹

Add To Cart Buy Now

  • Duration 3 Hours

  • Lectures 33 lessons

  • Enrolled 0 students

  • Category: Medical Device

  • 0 Quizzes

  • Language: English

  • Skill Level Short 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...