Medical Devices Regulations - US

Course outline:

  1. Laws and Regulations
  2. Quality System
  3. Software
  4. Combination and IVD Devices
  5. 510 Premarket Notification
  6. Device Modification
  7. PMA
  8. Clinical IDE and HDE
  9. Compliance with FDA
  10. Imports and Exports
  11. Working with FDA

Preparation of a New Drug Submissions eCTD

Preparation of modules 1 to 5 of the eCTD for drug submission.

Pharmaceutical Regulatory Affairs

This certificate covers the following outlines:

1- Healthcare product types
2- Stages of healthcare product life cycle
3- Common responsibilities of RA professionals
4- Regulatory agencies in major regulatory systems and timelines for drug registrations
5- Introduction to eCTD
6- Post approval activities and compliance

Medical Devices Regulations - Canada

Post-Graduate Certificate in Medical Devices Regulations - Canada

Topics:

  1. Medical Devices Regulation and device classification (Canada)
  2. Establishment license, labelling requirements and Importation
  3. Mandatory reporting (Incident reporting for medical devices: Guidance Document)
  4. Foreign Risk Notification for Medical Devices Guidance Document
  5. Guidance on Summary Report and issue-related analysis for Medical Devices