Archives

Is your business OK with OTK?

I love DIY projects! I find them truly irresistible. I relish each and every facet of them. From concept to completion, there is nothing I don’t enjoy. For me, there is nothing more rewarding than seeing something I created being brought to fruition. Perhaps it is the influence from my…

There is no I in Team

No doubt you have heard all the clichéd phrases; “There is no I in Team”, “There is safety in numbers”, “One is the loneliest number”, “No man is an island”, “Life is not lived in a vacuum”, etc….. Ever stop to think of why these phrases came about? As with…

Documentation, Medical Devices, and the FDA

This month the implementation date for MDD directive (2007/47/EC) comes due. There are a number of issues that require action by manufacturers (changes to the Essential Requirements, clearer requirements for clinical evaluation, changes to the QA of third parties) and the Notified Bodies ( higher requirements for auditing Technical Files)….

Green Your Product Information

Greening your product? What about your product information? We see it all the time and I’m sure you do as well. Companies are on the move with initiatives to “green” their operations and their products. It’s not just the big fortune 500 companies either, the push for green is being driven—and…

It’s just like riding a bike

Remember the first time you rode a bike? The first time you get on a bike, you’re not sure what to do and there seems to be so many things to manage. First there the ability to balance on the bike without falling off, then there are petals to pump…