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Biocompatibility: key questions
Read IMed’s Safety Assessment Strategy specialist’s guidance on biological safety, as Phil Clay kindly shares his expertise on both of the key recurring questions he’s always asked regarding biocompatibility. When clients start thinking about the biological safety of...
IMed Academy Launches
Giving skilled graduates an early career boost How many of us remember having a passion for a particular career, applying for numerous positions, but constantly being knocked back because the only thing we didn’t have was actual work experience? It’s the age-old...
Are you presenting the best possible PSUR data for your device?
If you are a manufacturer of a class IIa device or above (with a CE mark under MDR) you will already have had to prepare a periodic safety update report (PSUR) according to article 86 of MDR 2017/745. Paragraph (c) of that article requires that the PSUR sets out “the...
IVDR Transition Series – Episode 2
With only 10 months until the IVDR 2017/746 comes into effect, it is vitally important to work efficiently to transition both your Quality Management System (QMS) and the devices you manufacture, to the new regulatory requirements. A scattergun approach could mean...
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...