Global regulatory is becoming a very strategic problem for medical device companies. The landscape has become more complex as each agency has matured in their requirements. These continuously evolve and the change to them and change to products must be considered continuously to determine if re-filing is required.

This makes the difference between being able to sell hips, catheters and MRI machines in China, EU, Brazil, Argentina, etc. A PLM centric approach can enable companies to accelerate registration in those regions. This equates to massive revenue opportunities.

This is enabled by having a single copy of the submission data that is accessible in collaborative environment and can be quickly and reliably reused between regions.

Additionally managing this change process poorly can result in fines.  A core strength of PLM is managing change and all associated processes (such as supply chains used across a product assembly).  Therefore using this information while simultaneously tracking continuously evolving country requirements (including “Grandfather” rules) it is possible to determine with much greater simplicity and accuracy what on-market products are affected.  Similarly when introducing a new product or making a product change it is easier to understand what country requirements exist.

When building your Quality Management System (QMS) for your Medical Device Company, use this simple guide to develop the foundational three-legged-stool.  Realize that building an ideal QMS takes more than a good quality manual.  We must consider people, processes, and tools as critical components of a system that comes together in harmony.

I have been calling directly into the Life Sciences (LS) space for about a year and a half.  I will not call myself an expert, but given that I have been in the business world for over 30 years, I feel I have crossed over into the category of a “gray hair” and therefore I can have some relevant observations.  My below observations are in some ways provided as an outsider looking into the LS industry.

Believe it or not, there actually are some similarities.  Not sure if PLM is exciting?  Mike Tyson got a PLM lowdown for 10 minutes at DSCC this year, and you know what, the guy wasn’t bored.  Though, when it comes to Mr. Tebow, we have to be honest.  Put simply, it’s a catchy title, we are launching a new blog, and we are drawing you in!