Mantra Systems/Medical Affairs Training Course
Certificate

  • £145

Medical Affairs Training Course

Our training course offers an opportunity to understand the medical device regulation industry and to develop medical device regulation skills & knowledge.

Course structure

Please note: This training course was originally created for medical doctors seeking alternative career opportunities and therefore still has references to the 'Medical Affairs Associates Program'.

However, Mantra Systems has now opened the course to anyone interested in gaining a foundation in medical affairs, working in the medical device regulation industry and interested in working for Mantra Systems as a Medical Writer in the future.

1. Understanding the EU MDR

Introduction and overall course structure
Preview
Introduction to the MDR
Medical Affairs Manual
Structure of the MDR
What is a medical device?
Making devices available on the market
How to classify medical devices
General Safety & Performance Requirements
Quality Management Systems & Post-Market Surveillance
Risk Management
Clinical Evaluation
MDR requirements summary

2. Reviewing literature for MDR submissions

Literature Reviews introduction
Literature Reviews in context
Principles of a Literature Review
Introduction to Literature Review policy
Literature Review Policy
Introduction to search protocol
Example search protocol
Working with PubMed
Working with Google Scholar
Appraising a literature source
The importance of grammar & presentation
Literature review summary & post-course exercise
Post-course exercise
Beyond The Ward eBook 3rd Edition