Online Overview of Risk Management & ISO 14971:2019 [including Key Changes]
Comply Guru™ are proud to be partnering with Meddev Solutions in bringing to market this course!
Meddev Solutions are a team of QARA professionals, each with a minimum of 20 years’ experience, working in the medical device industry for both manufacturers and Notified Bodies.
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.
- 8 Hours
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The following topics will be covered on this course:
- Comprehensive Overview of EN ISO 14971:2019
- The key changes from 2012 > 2019
- The procedure and plan
- Risk Assessment tools
- Application to ISO 13485
- Relationship with other standards: the 60601/61010 series; Usability (EN 62366); Biocompatibility (ISO 10993)
++MORE INFORMATION COMING SOON!
This course is fully certified by Comply Guru™ & Meddev Solutions.
In order to successfully complete the course, each Learner will need to obtain a grade of 70% or higher in the final examination. Successful completion will entitle each Learner to receive a certificate of completion.
This course would be targeted at:
- Quality Assurance Professionals
- Quality Engineers
- Research and Design Engineers
- Internal Auditors
- Quality Managers
- Manufacturing Engineers
- Regulatory Professionals
In order to successfully complete this online course, each Learner will need to:
- Complete the online course modules and obtain 70% or higher in the final assessment (MCQ-based Assessment)
E-Learning System RequirementsThe below are the recommended requirements for each Learner in wishing to complete any of our online training courses or modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well.
Recommended Operating SystemsWindows 7/10, Mac OSX Sierra, iPad IOS10
Mobile DevicesComply Guru’s LMS is not available on a mobile app at this time. We recommend using a web browser on a mobile device in completing any online modules. However, if completing any final graded assessment, we recommend completing via a desktop browser.
Internet SpeedWe recommend using an internet connection of 256Kbit/sec or faster that will ensure that you can view videos and the online content
Recommended Internet Browsers
- Google Chrome 32 bit version 50 or later
- Safari 10 or later
Recommended SettingsWe recommend that the following settings are enabled:
- Pop-ups (in both Internet Browser and security software)
- Latest Version of Adobe Flash Player
- Latest Version of Adobe Acrobat Reader