26th February 2019
An EU based Authorised Representatives (EC Rep) may be needed if UK device businesses export devices to markets where a CE mark is required, after the 29th March 2019 deadline.
30th January 2019
The Medicines and Healthcare products Regulatory Agency (MHRA) have provided details of legislation to ensure continuity of supply of medicines, medical devices and clinical trials in a no deal Brexit.
7th December 2018
Matt Hancock, Secretary of State for Health & Social Care, has written a letter to suppliers of medical devices and clinical consumables to update them on the Department’s contingency planning approach.
19th October 2018
The Healthcare Innovation Roadshow, in collaboration with the West Midlands Academic Health Science Network (WMAHSN), National Institute for Health Research (NIHR) and Medilink West Midlands, took place on Thursday 18th October 2018, at iCentrum in Birmingham. The Healthcare Innovation Roadshow showcased the support that can be accessed by MedTech SMEs, from funding and adoption to […]
6th September 2018
A potential silver lining for medical device developers and manufacturers exists in the FDA’s response to 2016 “21st Century Cures Act”, with publication of a draft Guidance document outlining the agencies planned changes to the medical device approvals process and their oversight activities.
By MasterControl (MedilinkWM Patron). Perhaps nowhere is the life sciences industry seeing such rapid change and evolution as in medical devices. At the beginning of each year, it’s intriguing to look into a crystal ball to get a glimpse of what the upcoming year will look like.
21st March 2018
By Medilink member Fischer Connectors Challenges faced by designers of medical devices are among the most stringent in the world. Everything designed and manufactured must be safe for the patient and safe for the operator. Devices can be put through years of U.S. Food & Drug Administration (FDA) trials, with additional tests in Europe, so […]