Risk Management for Medical Devices

Online Overview of Risk Management & ISO 14971:2019 

We have a

100%

pass rate

Completion time                                    

8 hours                                                     

 

Support period                                     

90 days                                                        

Price

Coming Soon

Coming Soon

Submit your interest today

 

100% online

with tutor support when you need it

No additional fees

No membership or assessment fees 

We have partnered with Comply Guru, an expert leader in online training to make our Risk course available as an eLearning course.

Course Content

This online course will offer an interactive, comprehensive overview of risk management to medical devices based on ISO 14971:2019 which has just been released & includes an overview of the key changes.

The current law, medical devices directive 93/42/EC requires implementation of the state of the art, implementation of the harmonised standard provides presumption of conformity. The future regulation builds on the requirements of risk management.

EN ISO 13485:2016 requires medical device manufactures to implement a Quality Management System that has a greater emphasis on risk. This course for medical device manufactures has been developed to meet this more rigorous focus on risk management.


Assessment

 

You’ll be assessed through one online multiple choice exam. In order to successfully complete the course, you will need to obtain a grade of 70% or higher.

Successful completion will entitle you to receive a certificate of completion.

 

After the course is completed, you can still go back in during your access period to review the course content as many times as you like. 

Who should attend? 

▪   Quality Assurance professionals

▪   Quality Engineers

▪   Research and Design Engineers

▪   Internal Auditors

▪   Quality Managers

▪   Manufacturing Engineers

▪   Regulatory professionals

Submit your interest →

Make an enquiry below and one of our team will send you more information about the course and answer any questions you have. 

Address

Meddev Solutions Ltd

River House, Home Avenue 

Newry BT34 2DL

Email: info@meddevsolutions.co.uk

Social

  • LinkedIn
  • Facebook

Copyright © 2020 Meddev Solutions Ltd. All rights reserved.          Privacy Policy