2017 is now well and truly upon us and we are delighted to see that we are not too far from the finishing line of the UK-wide launch for the Emego assistive switch.
It’s amazing to think that we’ve been working on the Emego project since 2015 and it is now nearing the end, where does the time go! From our initial funding from the SBRI to working with real patients throughout South Yorkshire Hospitals, Emego has developed into an assistive product that we hope will bring real change for the good to people’s lives.
The GSPK Design engineers are in crunch time now as they put together the finishing touches and tweaks as the device gets sent for CE marking. CE marking is an electronics industry standard quality check that will put the class I medical device through its paces. Tests on the device will ensure that the Emego is safe to use by people in a wide variety of situations. The design team are confident that Emego will pass with flying colours and we will update you once we get the full results.
There will be further trials to study the effects of the medical device with real patient users. The anonymous trials will give the opportunity for people who use existing assistive technologies in their day to day life to try out Emego and check for things such as:
We are hoping that the study will produce positive results for the user and any small tweaks that need to be made can be done swiftly by the design team.
ISO 13485:2016 Accreditation
GSPK Design (the electronic engineers who are designing Emego) are delighted to announce that they are now fully compliant to ISO 13485:2016. This is a quality management approval set by the British Standards Institution (BSI). GSPK Design facilities are now fully compliant in the standards of medical device design and manufacture. This will give them the ability to work on other electronic medical device projects both in-house and as a service to clients.
So, to conclude we are well and truly on the road to launch and are excited as to what 2017 will bring. There are still a few boxes to tick to get to the launch stage but we are working hard with our collaborative partners to achieve this. We hope to update you with more information soon and a definitive release date.
If you would like to find out more about Emego or talk to a member of the team about a possible use you may have then we are more than happy to talk, just drop us a line on email@example.com
Till next time!