Risk management, dFMEA’s and fault tree analysis to ISO 14971
There are lots of activities surrounding medical device development, which are required to ensure regulatory compliance and ensure a design’s robustness. Much of this work can be time consuming and demanding for in-house design teams. We are eager to help and support our clients so can take full control of specific documents or regulatory requirements, to free up your team’s time for key activities and other projects within a business.
We can help with lots of design related activities including risk management to ISO 14971: 2012 through dFMEA’s, Fault Tree Analysis etc. and other documentation required for a medical device project.
If you are encountering difficulties, need expertise, resource or have a problem to solve then please give us a call, we will always try to help.