The answer to that question in a word is yes, life sciences labeling is immeasurably complex. To provide you with an illustrative contrast based upon my decade of experience within the field of information security, life sciences labeling is a far more complex subject than an area such as Cyber-security technologies. If you think my […]
Is Life Sciences Labeling Really That Complex? Read More »
Please enjoy this article in Innovatum’s continuing series containing timely content which is contributed by life sciences industry experts. Guest blog contributors will be presenting topics pertaining to labeling, regulatory management, and compliance considerations. The following article was submitted by… Joshua R. Dix, Suraj Ramachandran, and Darin S. Oppenheimer 1. Introduction Throughout its one hundred
Medical Device Labeling/Packaging Recalls 2010-2015 Read More »
Please enjoy this inaugural article in Innovatum’s new series containing timely content which is contributed by life sciences industry experts. Guest blog contributors will be presenting topics pertaining to labeling, regulatory management, and compliance considerations. The following article was submitted by Joshua R. Dix Regulatory Affairs Specialist Baxter Healthcare, Suraj Ramachandran Regulatory Affairs Manager Baxter
A Risk Based Approach To 510(k) Cumulative Review For Medical Devices Read More »
I was invited to speak at a UDI-centric conference a few weeks ago in which FDA made presentations and attended mine. Jay Crowley, Indira Konduri- (US FDA’s GUDID Program Manager) and representatives from GS1, ICCBBA and other organizations also presented. I was presenting on behalf of the AIM North America Healthcare Committee on the topic
What I Learned While Presenting in Front of the FDA About UDI Management Read More »
Medical Device Manufacturers the world over are striving to stay abreast of developments as regulatory bodies other than the US FDA release details concerning their approach to Unique Device Identification for medical devices. Taiwan is progressing in the area of UDI, having produced a guidance document late last year. Within this guidance information it is
Taiwan’s Version of Unique Device Identification Read More »
Jack Mazur, Principal JMG Recruiting, Pete Ginkel, Vice President ID Integration, Inc., and Lisa Fohey, CMRP PMP Director of Supply Chain Children’s Hospital of Wisconsin will be conducting a UDI Webinar hosted by JMG Recruiting from 1:00 pm to 2:30 pm Eastern on Wednesday January 6, 2016. Topics to be covered include Direct Part Marking technologies
UDI – Overcoming Obstacles and How To Maximize Value Webinar January 6, 2016 Read More »
The answer to this question is simple: have someone else do the work for you. Since there are two times (reasons) that validation is required there should be two approaches to making validation less onerous. Software Validation Reason #1 The first reason that validation is required is unavoidable, e.g. moving to new software. But since
How Do I Shave Weeks or Months from My Software Validation? Read More »
Innovatum Inc., a leading provider of labeling management and printing software as well as regulatory data upload solutions for the medical device and life sciences market, is a Silver sponsor at the 3rd Semi-Annual Medical Device & Diagnostic Labeling Conference taking place Sept. 24-25, 2015. The two-day event is being held at the, Hilton Del
Let’s face it, there are still those amongst us who grumble at the mention of having to comply with the UDI regulations. To them, it’s simply a matter of having to comply to stay in business. There are those of us however, who are advocates of the regulation and appreciate the benefits of UDI. We
Real Benefits of UDI in the Operating Room and Beyond Read More »
So far this summer is off to a sizzling start with Innovatum managing seven global labeling UDI implementation projects concurrently. Four of these projects had their go live take place in the month of June 2015 alone! In conjunction with successfully submitting significant amounts of product UDI attribute information to the FDA Production Global UDI
UDI Implementations In Full Swing With Innovatum Read More »