ISO 13485:2016 – time has run out!
May 8 2019
You’ll probably recall me mentioning ISO 13485, and its relevance to ensuring that you don’t fail? If you’ve reached the conclusion that it would be…
Archive
Another week, another funding opportunity
April 24 2019
Hot on the heels of last week’s article, there’s a further opportunity to get some funding to support your development project. This time, the criteria…
Funded regulatory and development support for SMEs
April 17 2019
Would £5,000 of fully funded product development or quality + regulatory support sound good to you? Are you working in a Staffordshire based business? Does…
You can’t afford to fail!
March 27 2019
Failure is expensive. Very expensive. Particularly when you’re developing a medical device. There are 5 things you should know about, to avoid the painful bite…
To conference, or not to conference, that is the question
March 6 2019
You’ve probably attended your share of industry conference over the years. You may have found some of them pedestrian, perhaps boring? So have we! Until…
Successful medical devices have great Project Management!
December 2 2018
Significant project delays are often experienced when activities fall out of sync and people become blinkered, rushing to finish their goals first and missing sight…
Considerations for Usability studies for medical devices with complex user groups
September 19 2018
Medical devices, and combination products, are typically targeted at therapeutic areas with large patient populations, so recruitment is fairly straightforward. Usability studies recruit participants from…
9 changes to FDA goalposts for medical devices
September 5 2018
A potential silver lining for medical device developers and manufacturers exists in the FDAs response to 2016 “21st Century Cures Act”, with publication of a…
FDA Quality System Regulation and ISO 13485
August 22 2018
A ray of sunshine has appeared for medical device developers seeking to market their devices in the US as well as other territories. Often, manufacturers…
Getting your medical device into the NHS
August 8 2018
Getting a device accepted by the NHS is often described as something of a “dark art”, a mysterious journey into the unknown. Having a map…