Recent and Current Projects

  • Design dossier review for NASDAQ quoted cardiovascular company
  • Multiple 510(k) applications for UK orthopaedic business
  • South American international product registrations for UK based female health company
  • CE Marking clinical study in three different countries for US based manufacturer of glucose monitoring system

In the blog

  • FDA commissions review of the 510(k) process

    Very interested to read recently that the FDA has commissioned the US Institute of Medicine (IOM) to review the 510(k) process. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183497.htm Whilst the review isn’t due to be complete until March 2011 I’ve already seen several articles from industry associations defending the current process. As part of the IOM there will be two public [...]

  • BSI acquires German Notified Body

    BSI has acquired German based Notified Body EUROCAT. EUROCAT is accredited for the certification of devices, IVD’s and active implantable’s and also offers product testing. See the official BSI press release here .

The UK office of Emergo Group (formerly Mediqol) is a medical device consultancy for clients looking for practical advice and support throughout the life-cycle of a medical product from assessing the regulatory pathway, clinical trials and quality system implementations – to product approvals, reimbursement and post-market surveillance.

Reduced time to market

We help clients reduce the time it takes to get their products on the market by using our knowledge of the product development process, medical device legislation and our relationships with the Notified Bodies and Regulatory Authorities

Reduced risk

We reduce the risk of an application being rejected through an in-depth knowledge of medical device legislation, requirements and expectations of Regulatory Authorities

Reduced cost

We save our clients money by managing the regulatory or clinical process and recommending effective strategies which will ensure approval with the minimum of resources

Expert team

With an expert team assembled from Departments of Health, Notified Bodies and industry we believe we have more medical device knowledge than any other specialist medical device consultancy in Europe

Full life-cycle assistance

We can provide assistance throughout the entire life-cycle of a medical device, from its initial conception and product feasibility right through to clinical trials, regulatory approval and post-market surveillance.