Our Blog
Why have a contract with distributors and local authorised representatives?
For medical device manufacturers, having appropriate contracts in place with your distributors and in-country representatives has never been more important. Not having a written contract in place with business partners could expose you to unnecessary risks. And anyone...
What Medical Device could you be using twice a day without realising?
Toothpaste! Seriously. Had you ever considered that toothpaste could be a medical device? This is something I hadn’t thought about until recently, after purchasing a new supply to sort out a sensitive tooth. As I inspected my investment in lasting dental relief, I...
Meet our new Regulatory Consultant, Kate Bandy
Meet Kate Bandy – by Al Mills Kate joins IMed as Regulatory Consultant on 12th April – so I gave her a brief grilling; How did you find your way into RA/QA and IMed? Completely by accident! Having enjoyed working in project management in Higher Education with The Open...
Med-tech Marketing: Think differently in the Evolving UK Landscape
Read IMed’s Med Tech Commercialisation Specialist’s guidance on marketing medical software products, as Steve Eames kindly shares his expertise on how to position your product in evolving Healthcare markets. For med-tech start-ups, or even for larger companies...
IVDR Language Requirements
The diverse range of live European languages presents a few challenges in determining which languages are required, for translation of your IVD’s product literature. The update to the EU IVD regulatory framework presents clarity on this, as they are only minimally...
What’s going on with Medical Devices Down Under?
So what's going on with Medical Devices Down Under? We’ve got Brexit’s repercussions to consider and of course the dates of application for the EU Medical Devices Regulations (MDR) 2017/745 and In Vitro Diagnostics Medical Devices (IVDR) 2017/746 are fast approaching...
3 things to consider on your medical device regulatory strategy – post Brexit
Do you know how rapid regulatory changes and issues like Brexit have affected your current regulatory plans? Are all your current or intended markets covered by the same regulations now or have some of your deadlines changed? Are you staying up-to-date with the...
Tackling Medical Device Software Under the New IVDR Requirements (Part 2)
In part 1 of tackling medical device software under the new IVDR requirements, I provided a summary of the first document published by the Medical Device Co-ordination group. As a follow up, I’d like to help identify the key things to focus on for meeting the General...
COVID-19: How IMed is Supporting the Industry
Here at IMed, our Quality & Regulatory Consultants have been busy adapting to the challenges which face us all, during this difficult time. Adaptation is a vital tool for any business in such an unprecedented commercial landscape. But it’s actually been great to...