Blog

PRISYM ID is a leading label lifecycle management solutions provider, with many year's experience implementing compliant solutions for our customers. Here we discuss best practices and interesting industry updates that we've come across.

 

'Labeling Challenges' Blog Series, Issue #6 The 3 Cs of Label Production

Recent UDI requirements have persuaded many medical device companies to review their labeling capabilities. This, alongside other regulatory, technological and market drivers, has led to a growing number of companies issuing Requests for Proposals (RFPs) to labeling solution vendors to address this key operational activity. However, many organizations still overlook the strategic importance of labeling and underestimate its impact right across the supply chain.

[Blog] The War on Error

Product recalls in the medical device industry are increasing – bringing a trail of destruction to companies’ operational efficiencies and profitability. Labeling error remains a common cause of recall – but it’s one that can easily be avoided.

[INFOGRAPHIC] The ABCs of IQ, OQ and PQ

LOL and OMG….today everyone knows what these internet slang terms mean and how to use them. You may also be familiar with Medical Device and Life Sciences specific acronyms for example IQ, OQ, and PQ. For those who are new to the very specific world of Life Sciences, we’ll try to debunk the myths around some of the terminology.  

‘Labeling Challenges’ Blog Series, Issue #5 Label Defect Control - Achieving zero-defect labeling

With the introduction of UDI, the need for medical device manufacturers to examine systems, processes and operations is intensifying. Product recalls in the medical device industry are increasing – impacting operational efficiencies and profitability. Labeling errors are a common cause of recall, but they can be easily avoided. The introduction of automated vision systems means there are more effective, efficient and secure ways of ensuring zero-defect labeling.

[INFOGRAPHIC] How one client saved $8M using PRISYM IDs print-on-demand solution

PRISYM ID’s print on demand solution, has enabled this blue chip medical device provider to print single-language Instructions for Use (IFU) at the time of shipment. This means that rather than their manufacturing sites including 23 Language IFUs with the product, they can instead print a country-specific IFU based on the intended destination of each product, and add it to the package at the time of shipment.

‘Labeling Challenges’ Blog Series, Issue #4: Reduce waste and spend - Insert management on demand

It is a constant struggle for medical device, pharmaceutical and clinical trial organizations to keep on top of all the newest regulations, certifications and required updates in a timely fashion. In this day and age of ever changing policies and country-specific labelling requirements, maintaining booklets has become a cumbersome manual process ̶ and they are expensive to produce.

‘Labeling Challenges’ Blog Series, Issue #3: Managing the complexities of global labeling requirements

All global manufacturers, including medical device manufacturers, wrestle with country of origin labeling requirements in one way or another. It can be especially confusing and complex in an environment where kits or packs are assembled, such as instrument manufacturing, or where complex devices are sold – which may include supply components from many territories.

[INFOGRAPHIC] The FDA's UDI Initiative – A Definitive Guide

It’s no surprise the medical device industry has been struggling with recalls for a number of years due to labeling errors. Did you know that during the period of 2003 to 2012 there was a 97% increase in medical device recalls?

‘Labeling Challenges’ Blog Series, Issue #2: Expansion and global labeling – Controlling the chaos

The medical device industry landscape is constantly in a state of flux with billions of dollars changing hands on a daily basis. Expansions. Mergers. Acquisitions. Restructuring. Spinouts. Downsizing. New regulations. Emerging markets. It’s all enough to make your head spin.