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Course / Course Details

QA/RA in Medical Devices

  • Rajashri Ojha image

    By - Rajashri Ojha

  • (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
  • 1 quizzes
Toggle all chapters
1 LMS SOP for students
15 Min

2 Medical Device Industry
15 Min

3 Medical Device Industry Video 1
1 Min

4 Medical Device Industry Video 2
1 Min

5 Medical Device Industry Video 3
1 Min

6 Global Medical Device market video
1 Min

7 Medical Device Industry PPT
15 Min

8 Articles
15 Min

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

10 IVD Regulations
15 Min

11 Frequently Asked Questions about IVDR
15 Min

12 IVDR PPT
15 Min

13 Guidance on Classification
15 Min

14 Article on clinical requirements
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

13 IND-MDR-2017 Video lecture
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 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 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 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 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 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 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 MD-QA FINAL EXAM [Quiz]
1 Hour 40 Min

Instructor

Rajashri Ojha

4 Rating
1 Reviews
49 Students
154 Courses

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  • Category: Medical Devices

  • 1 Quizzes

  • Language: English

  • Skill Level Regular Courses

  • Certificate of Completion

  • 90 Days Access

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