Our Blog
Medical Writing Services – the explanation
IMed’s Medical Writing service (sometimes also called ‘Clinical Writing’) is provided by Medical Writing experts. This is important, because not just anyone can write and sign off a Clinical document in support of your medical device, if it’s to be accepted by the...
IMed launches UKRP Services for Manufacturers outside UK
Do you need a UK Responsible Person to meet your UK regulatory requirements? If you do – or even if you aren’t sure if you do, IMed can help. Post Brexit, medical device manufacturers based outside the UK, selling or wishing to sell their products in the UK – will...
Where can you obtain sufficient acceptable clinical data?
If your device is already CE marked, you have probably read MDCG 2020-6 (published in April 2020), which provides guidance on the clinical evidence needed for legacy products. You would have also developed a Clinical Evaluation Report (CER) for your devices and...
What else can be said about IVDR?
What else can be said about IVDR? With so many IVD firms still to submit, the deadline is now closer than you might realise… I’ve seen lots of articles, in the trade press and IVD forums, about the fast-approaching EU IVDR 2017/746 deadline. So when I was asked to...
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...