Countdown to MDR 2017/745
Do you need help taking your medical device to market ?
Are you daunted by the thought of expanding your existing devices into new markets?
Are you uncertain if your business is keeping up with the ever-changing medical device regulation?
Whether you have an existing device, an improved model, or a brand-new idea, IMed Consultancy has all the knowledge and regulatory experience that you will need, to face the challenges involved in placing medical devices on the market and keeping them compliant. You can leverage our expertise, taking the pain of regulation out of your business and speeding up the process. IMed has been supporting medical device companies for many years, in multiple markets. Our team can help you navigate all areas of quality assurance and regulatory affairs. We’ve all worked in industry too, so we’ve been in your shoes and appreciate what a departure from your day to day job a regulatory project can be, and the potential negative impact that time lost from your day to day activities can have on your business.
At IMed, we are doing regulatory work in multiple territories every day, so can assist at all levels and at all stages in the life of your medical device;
• Early device design
• Regulatory planning
• Product development
• Market release
• Emerging regulatory obstacles
Or we can simply be on hand for support and advice!
But having IMed on your team will make you faster to act and give you the agility to adapt. We can even help you with any non-conformities raised following a Technical Documentation File review or periodically audit and update your Quality Management System, to keep everything up to scratch.
EU MDR Regulation (2017/745)
IMed recognised immediately that the implementation of the Medical Devices Regulation (MDR) 2017/745 demands much more of Medical Device Businesses, than its predecessor, the Medical Device Directive (MDD). So, we’ve worked hard to make sure we understand all the detail and the likely changes that companies now face, so that you don’t have to.
To help you to understand how this affects you and your business, IMed can manage all your transition needs in moving your devices to the new MDR and we can influence and educate your team, so that they understand the key changes in regulation, and related documentation, leaving your staff armed and your business poised for the future against the new regulatory landscape.
At IMed, we feel that we do things a bit differently. We really appreciate that our clients give us their trust when we are appointed, so we feel a real sense of responsibility and place huge emphasis on our client relationships, irrespective of size. As a result, we now often work with clients, time and time again and it really helps clients to work with people that they know (and like) and whose expertise is freely available to them.
As your experts in medical device regulation, it’s our job to find you the right solution for your device with an eye on the budget. So just ask us for whatever you need, and we’ll find the best way to deliver it to you. And, if you aren’t sure what you need – just talk to us and we can help with that too!