The Medical Device Single Audit Programme (MDSAP) is starting to gain acceptance in the medical device industry. The outcome of more than five years of work by regulatory bodies from Australia, Brazil, Canada, Japan and the US, MDSAP allows a recognised auditing organisation to conduct a single audit of a…
Currently, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for just under a third of applications and updates for European medicinal product marketing authorisations – but on 29 March 2019 the UK will no longer be part of the European Union (EU). I was struck by the enormity…
As part of our review of the new European Medical Devices Regulation (MDR) earlier this year, one of the topics that caught our eye was the expansion and clarification of the rules regarding clinical data for medical devices.The difference between a clinical investigation and a clinical evaluation Many people colloquially…
The new European Medical Devices Regulation (MDR) introduced by the European Commission (EC) has led to a lot of discussion around the implications for getting products on to the European market. But what about products that are already on the market? What does the new regulation mean for these so-called…
The words ‘post-market surveillance’ (PMS) appear 129 times in the new European Medical Devices Regulation (MDR). This repetition is not accidental. The requirements for manufacturers to ‘actively and systematically’ gather, record and analyse relevant data for the lifetime of each device they market is work most companies had not been…
Connectivity is a reality, it’s part of our daily lives, and the ‘quantified self’ is a recognised phenomenon be it through wearable health and activity trackers or your smart phone. The personal information created must be taken seriously, and developers must not only deliver a great user experience but also…
Meet the team at Cambridge Design Partnership – a brief profile of the experts, engineers and interesting people that work here. This month we’re talking to Ryan Noble, a senior quality specialist. What was your background prior to joining CDP?I spent 16 years at a large international pharma company, working…
Innovative technology and design consultancy Cambridge Design Partnership today announced that due to the huge success of Europe’s first AAMI Human Factors for Medical Devices course they will be sponsoring more courses in 2015.Cambridge Design Partnership worked with the US based Association for the Advancement of Medical Instrumentation (AAMI) and…