Design Control 2020 - Risk-based Design Control - The New Paradigm for Medical Device Design

Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device. Design control is not only a requirement of the QMS but risk management must be applied to the design control process itself.
If you are constantly struggling to create, manage, and maintain all of the information found in the various Risk Management documents and files, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.
The 2019 approach to design control
What do FDA and ISO say about it
How do you present it to management
What are the key steps in risk-based design control
How to implement risk-based design control in your company
Bringing it all together – links to design and process
Speaker:
Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems.