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Course / Course Details

Medical Device-Quality Assurance

  • 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, Biomedical engineer 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 course will cover Introduction to various medical device regulatory bodies, QMS [ISO 13485-2016, Risk Management & Risk Analysis- ISO 14971, Technical File Preparation, Regulatory Submissions to Regulatory Authority-India, US, Europe

Course Curriculum

  • 10 chapters
  • 100 lectures
  • 1 quizzes
  • 3 Hours total length
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1 Medical Device Industry
15 Min

2 Medical Device Industry Video 1
1 Min

3 Medical Device Industry Video 2
1 Min

4 Medical Device Industry Video 3
1 Min

5 Global Medical Device market video
1 Min

6 Medical Device Industry PPT
15 Min

7 Articles
15 Min

8 The changing landscape of the medical devices industry in the APAC region
15 Min

9 IVD Regulations
15 Min

10 Frequently Asked Questions about IVDR
15 Min

11 IVDR PPT
15 Min

12 Guidance on Classification
15 Min

13 Article on clinical requirements
15 Min

1 Technical Documentation
15 Min

2 PPT
15 Min

3 Articles/guidances 1.1
15 Min

4 Articles/guidances 1.2
15 Min

5 MDR Technical Documentation Checklist
15 Min

6 Videos Section 1 part 1.1
1 Min

7 Videos Section 1 part 1.2
1 Min

8 Videos Section 1 part 1.3
1 Min

9 Videos Section 1 part 1.4
1 Min

10 Videos Section 2 part 1.1
1 Min

11 Videos Section 2 part 1.2
1 Min

12 Videos Section 2 part 1.3
1 Min

13 Videos Section 3 part 1.1
1 Min

14 Videos Section 3 part 1.2
1 Min

15 Videos Section 3 part 1.3
1 Min

16 Regulatory Documents-DHF, DMR, DHR and TF Video 1
1 Min

17 Regulatory Documents-DHF, DMR, DHR and TF Video 2
1 Min

1 Risk Management System
15 Min

2 Risk Management Video 1
1 Min

3 Risk Management Video 2
1 Min

4 Risk Management Video 3
1 Min

5 Risk Management Video 4
1 Min

6 Risk Management Video 5
1 Min

7 Risk Management Video 6
1 Min

8 Risk Management Video 7
1 Min

9 Risk management PPT
15 Min

10 Articles/Guidance 1.1
15 Min

11 Articles/Guidance 1.2
15 Min

1 Quality Management System
15 Min

2 ISO 13485:2016 part 1 Video 1.1
1 Min

3 ISO 13485:2016 part 1 Video 1.2
1 Min

4 ISO 13485:2016 part 1 Video 1.3
1 Min

5 ISO 13485:2016 part 1 Video 1.4
1 Min

6 ISO 13485:2016 part 1 Video 1.5
1 Min

7 ISO 13485: 2016 part 2 Video 1.1
1 Min

8 ISO 13485: 2016 part 2 Video 1.2
1 Min

9 ISO 13485: 2016 part 2 Video 1.3
1 Min

10 ISO 13485: 2016 part 2 Video 1.4
1 Min

11 ISO 13485: 2016 part 2 Video 1.5
1 Min

12 ISO 13485: 2016 part 3 Video 1.1
1 Min

13 ISO 13485: 2016 part 3 Video 1.2
1 Min

14 ISO 13485: 2016 part 3 Video 1.3
1 Min

15 ISO 13485: 2016 part 3 Video 1.4
1 Min

16 ISO 13485: 2016 PPT
15 Min

17 Article/guidance ISO 13485 standard
15 Min

1 EU-MDR video 1
1 Min

2 EU-MDR video 2
1 Min

3 EU-MDR video 3
1 Min

4 EU-MDR video 4
1 Min

5 EU-MDR video 5
1 Min

6 EU MDR PPT
15 Min

7 NEW EUROPEAN MEDICAL DEVICE REGULATION (MDR) COMES INTO EFFECT IN 2020: CHANCES AND CONSEQUENCES FOR STAKEHOLDERS
15 Min

8 Impact of changes under the new EU Medical Devices Regulation (EU) 2017/745 to international registrations:
15 Min

9 Guidance
15 Min

10 Medical Device Regulation in EU
15 Min

1 USFDA Video 1
1 Min

2 USFDA Video 2
1 Min

3 USFDA Video 3
1 Min

4 USFDA PPT
15 Min

5 Medical device safety plan
15 Min

6 FDA regulatory pathways for medical devices
15 Min

7 Medical Device Regulation USFDA
15 Min

1 Sugam Portal video 1
1 Min

2 Sugam Portal video 2
1 Min

3 BIS SUBMISSION video 1
1 Min

4 BIS SUBMISSION video 2
1 Min

5 Sugam Portal PPT
15 Min

6 BIS Submission PPT
15 Min

7 Sugam Portal Submission: User manual guidance
15 Min

1 MDD to MDR Difference and similarities Video 1
1 Min

2 MDD to MDR Difference and similarities Video 2
1 Min

3 MDD to MDR Difference and similarities Video 3
1 Min

4 MDD to MDR Difference and Similarities PPT
15 Min

5 Article/guidance MDD to MDR Key Changes
15 Min

1 Indian Medical Device Rule 2017
15 Min

2 MDR 2017-India Video 1
1 Min

3 MDR 2017-India Video 2
1 Min

4 MDR 2017-India Video 3
1 Min

5 MDR 2017-India Video 4
1 Min

6 Medical Device Rule 2017 PPT
15 Min

7 Guidance 1
15 Min

8 Guidance 2 - MDR17- Regulations
15 Min

9 Guidance 3 - Medical Devices Rules, 2017
15 Min

10 Guidance 4 - SUGAM user manual
15 Min

11 Guidance 5 - mdr, 2017
15 Min

12 MDR 2017 India Lecture video
1 Min

1 MD-QA FINAL EXAM [Quiz]
1 Hour 40 Min

Instructor

Rajashri Ojha

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  • Duration 3 Hours

  • Lectures 100 lessons

  • Enrolled 0 students

  • Category: Medical Device

  • 1 Quizzes

  • Language: English

  • Skill Level Regular Courses

  • Certificate of Completion

  • 7 Days Access

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