The Role of Simulation in the Approval Process of Medical Devices

Image Courtesy of CADFEM Medical GmbH 

This Seminar will be offered in Dublin and Galway. Other venues on request. Please contact us for dates, venue, further details.

To meet the ever more challenging requirements for medical devices in the health care sector, more efficient methods in product development and assessment are needed. Apart from classical approaches like laboratory tests, animal models and clinical studies, computer-aided simulation proves to be a very promising tool to speed up the approval process and to further enhance patient security. Simulation results can support regulatory assessment in the different phases of the product life cycle, for example when it comes to worst-case assessments of dimensions and variants or test load definitions of experiments. Furthermore future requirements in respect of the Medical Devices Ordinance – MPV for patient-specific implants can be addressed.  

Target audience:
​This 1-day seminar is aimed at all engineers, project managers, and executives who plan to use simulation methods in the frame of their medical device development in order to speed up the Declaration of Conformity of their products.

Why attend?
– Understand how your analysis will meet the security requirements of your biomedical devices. 
– Reduce warranty damages, unnecessary iterations and liability risks to a minimum.
– Verify and improve your quality processes so that in the event of a claim any accusation of negligence in the analyses performed can be disproved.
– Learn the principles of the technical documentation FDA Guidance 1807, its compliance.

Agenda in brief:
M1: Basics of conformity assessment procedure
M2: Simulation in the approval process
M3: Best Practice and basics of technical documentation
M4: Practical – real life examples

Applied software: ANSYS Mechanical

The complete agenda and further information will be provided here shortly.  If your request if urgent, please contact info@cadfemireland.com

 

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