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Course / Course Details

Medical Devices Regulation – 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

  • 12 chapters
  • 53 lectures
  • 0 quizzes
  • 3 Hours total length
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1 Documentation
15 Min

1 Agenda
15 Min

1 Medical device registration in India overview
15 Min

2 MDR 2017 PPT
15 Min

3 Medical Device Rule Video sadhwani 1
1 Min

4 Medical Device Rule Video sadhwani 2
1 Min

1 Changes introduced in MDR
15 Min

2 MDR and MDD PPT
15 Min

3 MDD and MDR Video
1 Min

1 Quality Management system
15 Min

2 MDR -QMS- PPT
15 Min

3 QMS -part 1-Video 1
1 Min

4 QMS -part 1-Video 2
1 Min

5 QMS part 2-Video 1
1 Min

6 QMS part 2-Video 2
1 Min

7 QMS part 3-Video 1
1 Min

8 QMS part 3-Video 2
1 Min

1 MDR EU
15 Min

2 EU MDR Requirement and Change PPTs
15 Min

3 MDR EU part I Video 1
1 Min

4 MDR EU part I Video 2
1 Min

5 MDR part 2 Video 1
1 Min

6 MDR part 2 Video 2
1 Min

7 MDR EU part 3 Video 1
1 Min

8 MDR EU part 3 Video 2
1 Min

9 MDR EU part 4 Video 1
1 Min

10 MDR EU part 4 Video 2
1 Min

1 Clinical Evidence
15 Min

2 clinical evidence PPT
15 Min

3 Clinical evidence part 1 video 1
1 Min

4 Clinical evidence part 1 video 2
1 Min

5 Clinical Evidence part 2 Video 1
1 Min

6 Clinical Evidence part 2 Video 2
1 Min

1 Overview of Risk Management
15 Min

2 Risk management
15 Min

3 Cyber security Video
1 Min

1 Overview of design and development
15 Min

2 Design and development ppt
15 Min

3 Design and Development part 1 Video
1 Min

4 Design and development -2 Video
1 Min

5 Design and development-3 Video
1 Min

6 Design and development 4-Video
1 Min

1 MDD to MDR
15 Min

2 MDD to MDR PPT
15 Min

3 MDD to MDR Video
1 Min

1 Overview of Medical device in US
15 Min

2 Medial device approval US FDA PPT
15 Min

3 Approval in US FDA Video
1 Min

1 Medical device Overview in India
15 Min

2 MDR India PPT
15 Min

3 Medical device regulation in India-Video
1 Min

4 Sugam Portal Video
1 Min

5 Sugam portal 2 Video
1 Min

Instructor

Rajashri Ojha

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  • Duration 3 Hours

  • Lectures 53 lessons

  • Enrolled 0 students

  • Category: Medical Device

  • 0 Quizzes

  • Language: English

  • Skill Level Regular Courses

  • Certificate of Completion

  • 7 Days Access

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