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European Commission Proposes IVDR Transition Assistance…

European Commission Proposes IVDR Transition Assistance…

...to Keep IVD Products on the Market and Available to Patients On the 14 Oct 2021, the European Commission released a proposal for amended transitional arrangements to Regulation (EU) 2017/746 (IVDR) as the industry moves closer to the Date of Application (DOA) of 26...

Is your old CER still compliant under MDR?

Is your old CER still compliant under MDR?

Revamped your device’s CER in the last 24 months? If the answer is NO, then there’s a high likelihood that your ongoing compliance is at risk. IMed’s Chief Medical Writer Ana Quinn offers a really quick way to double check your current status. Clinical evaluations...

IVDR Transition Series – Episode 3

IVDR Transition Series – Episode 3

Stephen Quinn continues his IVDR transition Blog series and extolls the virtues of Gap Assessments when embarking on regulatory transitions. Read on to learn how this crucial business tool could be the difference between a successful transition or falling at the final...

Ciaran Rooney joins the IMed Academy

Ciaran Rooney joins the IMed Academy

Al Mills interviews our new recruit to the IMed Academy: Ciaran Rooney IMed’s Academy grew by another one on 21st September when Ciaran Rooney joined the Medical Writing Department. Al Mills caught up with Ciaran at an IMed Team meeting to find out more about his...

Jonathan Ripley joins the team at IMed

Jonathan Ripley joins the team at IMed

We are delighted to introduce IMed’s latest key hire, Jonathan Ripley, who joined the IMed management team on Monday, as Head of our growing IVD department. Al Mills gave him the usual day-one grilling, so read on to find out more about Jonathan and his views on...

The regulatory pathway – expert involvement is a must!

The regulatory pathway – expert involvement is a must!

Bringing a new product or service to market is a multi-disciplinary challenge. Not only do you have to be concerned with the design and manufacture of your product, but you also need to consider any intellectual property and patent issues (both protecting your work...

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

Ana Quinn tells us about the impact of career mentoring on her career and why it's important to her to pay it forward. 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...

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...