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The medical device design consultancy services that we provide are based on expert technical knowledge as well as a deep understanding of both the design documentation and the overall regulatory requirements.
In order to legally market all but the lowest risk types of medical device in the US and EU, a medical device design history file or design and development file is needed in order to describe the results of the design process used.
In other situations as well, following this process can also be hugely beneficial to ensure that the developed product performs as well as possible.
The requirements in the US quality system requirements for design control (21 CFR 820.30) and those in ISO 13485:2016 for design and development are broadly similar and necessitate a set of design documentation. Some of the best guidance available on the subject is from the FDA and this is the process that we use in our medical device design consultancy work.
An important part of the design process that is often not afforded sufficient effort is the generating of design inputs, the set of physical and performance requirements for the device. Once these are adequately defined then the whole testing regime is clear, meaning that no unnecessary testing is conducted, or any important assessments are overlooked.
A typical medical device design consultant who also provides testing services will focus on just performing these assessments, at the expense of other design stages, and will often suggest additional testing which is usually costly and time consuming.
The medical device design consultancy services that we provide are based on expert technical knowledge as well as a deep understanding of both the design documentation and the overall regulatory requirements. This means that we can define the testing that is required and open additional options in choosing more general testing service providers.
So, whether you need assistance in a new product development, or just retrospectively completing missing design documentation to supplement a medical device technical file or 510k, then we have a medical device design consultant who can help.
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