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The crucial journey from ISO 9001 to ISO 13485 – and why…

The crucial journey from ISO 9001 to ISO 13485 – and why…

Jacob Tyson, one of IMed’s Medical Writers, explains why ISO 13485 is key to medical device manufacturers QMS More and more manufacturers are contacting IMed to determine if their product is now classified as a medical device and when they find out that it is, they...

Career Mentoring with Ana Quinn

Career Mentoring with Ana Quinn

In only my seventh year in the workplace, after graduating with a bachelor’s degree, I find that I already have the position I always wanted; Chief Medical Writer at IMed and a budding team of my own. I often wonder how my unexpected and rather whirlwind career...

Jacob Tyson joins the IMed Academy

Jacob Tyson joins the IMed Academy

Al Mills interviews one of our first recruits to the new IMed Academy: Jacob Tyson I caught up with Jacob at the end of his 3rd week with IMed, to find out more about him and see how he’s getting on; Where are you from? I was born in Hull, but moved to South Wales...

Biocompatibility: key questions

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

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?

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

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

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

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...