Using Compliance To Your Advantage – 2: A US Life Sciences Leader

By Neil Gleghorn, CEO and Founder, Kallik The last few blogs have been on the topic of making a helpful virtue of a business necessity – that of gearing up for new sector compliance moves that you need to ready for, especially UDI. The aim: use UDI as a spur to improve lots of labeling…


Using Compliance To Your Advantage – 1: Coloplast

By Neil Gleghorn, CEO and Founder of Kallik Last time we spoke (‘Could Hassles Like UDI Be Blessings In Disguise?’), I discussed the way that gearing up for things like the imminent UDI legislation coming out of the US (and similarly in Europe/RoW) can work to your advantage. That’s because you can gain a lot…


Could Hassles Like UDI Be Blessings In Disguise?

By Neil Gleghorn, CEO and Founder of Kallik Having a busy Q2? We certainly are here at Kallik – especially around helping customers deal with their regulatory obligations. When we spoke before, (‘Compliance Only Ever Matters If You Need To Demonstrate It!’) we started to flag up the importance of new compliance changes coming your…


Using Compliance As a ‘Mother of Invention’ Can Be A Smart Way to Operate

We’ve been having a discussion about compliance: why it matters and how you can see it as not just a necessity but as a ‘mother of invention,’ – a way to sharpen up your business processes, and as a ‘free’ benefit of putting all you need in place to be compliant. Here’s another benefit that…


Compliance Only Ever Matters If You Need To Demonstrate It

By Neil Gleghorn, CEO and Founder, Kallik Last time we started opening up the interesting question of how and why compliance matters . Let’s pursue this point for a bit longer, as I think it is an important one. Here’s a puzzle to start us off: how do you know you are compliant? When everything…


Delivering ROI from UDI

By Ashley Goldie, Sales and Marketing Director, Kallik Medical device manufacturers can turn new product identifier requirements to their competitive advantage if they treat them as an excuse to make bigger changes to the way they manage label creation. Here we chart the experiences of Coloplast, a German medical device company and large US manufacturer…


Ensure You Understand The Value Of Compliance

By Neil Gleghorn, CEO and Founder of Kallik We’ve talked before about some of the pressures and drivers of change the medical device sector is dealing with right now, so I’d like to return to some of the problems discussed there, which interestingly strike me as connected to some of the main reasons that we…


Are You On Top Of Recent EU Medical Device Regulation Change?

By Neil Gleghorn, CEO and Founder of Kallik We’ve been talking about the changing shape of legislation in the medical devices market, so it might be useful to hone in on a specific example to help illustrate why labelling will be directly in the firing line – and maybe sooner than you think. Back in…


How Can Technology Help You Deal With A Changing Medical Device Market?

By Neil Gleghorn, CEO, Kallik Last time, we laid out a set of big drivers of change in the medical devices context that will impact your business in the next few months. Let’s switch tack now and start talking less about problems and business context and more about the practical help a company like Kallik…