UK regulatory services for
international medical device manufacturers

About Us / Uber Uns / Qui sommes-nous

The team at UKMDR is headed by Toby Hamblin who has nearly two decades of regulatory experience in Europe, the United States and China.

While Toby has experience working with companies of all sizes from start-ups to large corporations. his solutions-led approach has been particularly effective in navigating new regulatory territory that has included obtaining, for a European company, the first ever FDA de Novo 510(K) for a biological medical device and identifying innovative clinical data strategies to fast track regulatory acceptance in the UK.

Highly experienced in all aspects of ISO 13485, including the vigilance that is critical to the role of Responsible Person in the UK, the small team at UKMDR is well equipped to navigate through the unchartered territory of the new UK medical device regulations for which the Medicines and Healthcare products Regulatory Agency (MHRA) will be providing additional guidance for the foreseeable future.