Our Blog
Have you determined your device’s lifetime?
Have you determined your device's lifetime? Did you know that there are a total of eleven mentions of a device’s lifetime within the MDR but none of these actually define this new term? We know it’s not quite life expectancy, it’s not the same as the expiry date, nor...
How can 3D Printing Influence your Medical Device Business?
How can 3D Printing Influence your Medical Device Business? - by Terence Logan When most people think about 3D printing, they generally think of prototyping or something they watched on TV; Grey’s Anatomy printing a heart valve, for example. But where does the reality...
What do we do now that EUDAMED is delayed?
What do we do now that EUDAMED is delayed? - by Ana Quinn Article 33 of the MDR required the setting up of a European database on medical devices: the widely feared EUDAMED! However, with this now being delayed to May 2022, MDCG 2021-1 has just been published with...
Happy 9th Birthday IMed
To celebrate our 9th Birthday on 6th June 2021, we got the whole team together for the first time in over a year, at our offices in Bloxham. Our specialist consultants largely work remotely or on site with clients (when it’s safe to do so), so getting together to...
Ana Quinn joins the growing team at IMed ahead of our 9th Birthday
Meet Ana Quinn – by Al Mills Yes that’s right; IMed’s growing team increases by one today, in the form of Ana Quinn, our new RA and Clinical Specialist Consultant on 1st June, just 5 days before we’ll be singing Happy Birthday to our business after 9 years in the...
Are you ready for the changes to Canada’s medical device regulations?
Medical device vigilance and post-market surveillance requirements are changing in Canada. Are you ready for the changes to Canada’s medical device regulations? If you are involved in the manufacture or import of medical devices for the Canadian market, you need to be...
Could you be limiting the sales of your medical device by not considering self-care users within your design process and IFUs?
Self-Care The combination of the increasing prevalence of chronic diseases and working through the challenges which the COVID-19 global pandemic presented for patient care, has without question highlighted the need for increased self-care. But who is going to support...
Deadlines keeping you awake?
Deadlines keeping you awake? Wish you had more staff? IMed can help you to optimise your regulatory pipeline……….without breaking the bank! All businesses have to find a way to manage their short and long-term projects concurrently. And when staff changes occur,...
To Google Translate or Human Translate? That is the trillion to one question
Read IMed’s Translation Specialist’s guidance on translating IFUs into Japanese, as Julia Tuff kindly shares her expertise on whether a machine translation service is enough or whether you need a human linguist. Google translate, the machine translation (MT) service...