In-Vitro Diagnostics (IVD)
Countdown to IVDR 2017/746
Is your business part of the (IVD) supply chain?
Or perhaps you are an entrepreneur who needs guidance on how to take your IVD prototype into the regulated market?
IMed has over 20 years’ experience in the IVD industry and a comprehensive knowledge of global quality and regulatory requirements in this area. So, whether you are an IVD Manufacturer, Authorised Representative, Importer or Distributor within the EU, IMed can help.
We offer a wide range of services and have extensive IVD compliance knowledge, which you can tap into, strengthening your organisation ‘s regulatory competence at every point of the product lifecycle. Our current client base is extremely varied, and we support all sizes of client from SMEs to long established market leaders.
If you have a new IVD – or even an idea for one, we can assist in the early stages with design, product development, regulatory planning, potential markets and ongoing maintenance for any emerging problems or regulatory changes. The sooner we are involved, the more focused activity can be on both sides and this will speed your path to market with your device.
EU IVD Regulation (2017/746)
You may have read up on the new EU IVD Regulation (2017/746), trawling the internet and even watching webinars about what’s expected of your organisation under the new rules. But attempting the transition process alone is another matter. IMed has the expertise and resources to help you migrate your products, documents and technical files seamlessly, while you keep you focused on your day job.
To manage your transition, first, we’ll classify your devices, assess gaps in compliance and identify any weaknesses in QMS processes, product verification, validation data or clinical evidence. This will enable us to devise your new regulatory strategy, which will give a clear gap analysis and step by step plan for you to follow. Once we’ve implemented the changes, we will help you to plug those regulatory gaps, then IMed will go back to the beginning to check all of our work and yours; just to make sure we have achieved everything necessary to meet the new requirements. Then we can get your data and documentation submitted to the Regulator and your IVD approved under the new rules.
But even if you feel you’ve understood what’s required and done the work on the transition process yourselves, we are more than happy to review your documentation or simply offer advice on the parts you are less sure about. IMed are on hand as your regulatory partner and advisors, at whatever level you’d like.