Medical Device Design

We understand exactly how to get your medical device idea ready for market. We have a clear and proven product development programme that we use to ensure that you get the right product for market. We understand the often-complex programme of device design, and all of the processes and procedures that need to be considered to get the CE mark. We can take on the whole project or can work as part of your team, depending on your requirements. 

We give you access to highly skilled engineers who can understand the science and choose the right technologies to develop your ideas. We plan projects carefully using established processes to ensure you get value for money by coming in on budget and on time. Our engineers are trained to manage out risk. We are ISO13485 accredited, with an established quality management framework designed to meet regulatory requirements. 

Our portfolio page has a selection of the work we do at eg technology. Please call us if you would like to talk about your design requirements. 

Glossary

The production design is the final output from the Transfer to Manufacture phase of the Design Process. It will specify the manufacturing and assembly methods and materials suitable for the expected production quantities and is typically thought of as the ‘finished design’. 

  •  Software Production Release – The final release of the software will have been tested and verified on full production specification equipment. In some projects the pre-production release and production release will be the same version of the software. The term ‘final’ refers to the end of the phase of development and does not imply that the software will be bug-free. Despite extensive testing, it cannot be warranted that the final release software is completely without bugs. 
  • Depending on the nature and complexity of the software it may therefore be necessary to undertake support and maintenance activities to address software issues if they are discovered after commercial release. Any future changes will be conducted as a new development project and released as later versions, under change control. 

The production design will be validated against the up-to-date product requirements specification and can be used to verify the specification. It is expected that the production design will be released or sold by a client to third parties. 

A production design is normally accompanied by a Technical File or documentation as agreed with the client which details how the design can be put into production and how the device meets relevant regulations to allow the product to be put onto the market, e.g. CE marking. 

Final EMC, electrical safety and essential performance test certificates will only be valid if the units tested are full production design units or equivalent in design, for example in pre-production prototypes. Alpha and Beta prototype units can all be used to gain confidence that the design will pass EMC and electrical safety and essential performance testing but a final certificate (that would be accepted in a court for example) can only be offered against the final production design units or equivalent pre-production prototypes. 

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