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.

 

[INFOGRAPHIC] EU MDR – Is the Industry Planning for It? Are You?

Whether you’re producing medical devices within Europe or supplying to Europe from the rest of the world, as a manufacturer or supplier, you will need to adhere to the EU MDR by May 2020.

Survey reveals that only 17% of the respondents are aware of the changes that come with the EU MDR

Here at PRISYM ID, we have recently conducted a survey of international medical device manufacturers, to ascertain their understanding of EU MDR, and the implications of the new regulation on label lifecycle management.

[INFOGRAPHIC] UDI Lessons Learnt. Embrace them for the EU MDR Implementation

The introduction of UDI requirements into the EU is good news for organizations that are already along the pathway of adopting systems and processes to support FDA UDI compliance.

Introducing PRISYM 360 - The Only Labeling Solution Dedicated to Life Sciences

Across the Life Sciences industry worldwide, the way in which organizations approach the design, creation and printing of labels has historically been both inconsistent and fragmented. Often regarded as static pieces of content, labeling processes have typically resided in operational silos, separate from product production.

EU MEDICAL DEVICE REGULATION (MDR) – The Useful Guide to Labeling Compliance

The new regulation  is a fundamental revision to better control and identify medical devices products and improve safety and transparency through clear accountabilities, standard processes and data, technological advances and the establishment of an EU database (Eudamed). Labeling processes and systems will be key to meet the requirements of EU MDR/EU IVDR.

Best Practice Guide – Label Image Management

By Daniel Green Images are increasingly used in as an integral part of label design to communicate critical information. Their use, therefore, should be bound by the same governance and audit processes as the rest of the label itself.

Sharing Knowledge & Experience in Label-Specific Challenges

By Tim Fischer I recently took part and chaired an interactive session where executives and other medical device industry specialists came together to discuss challenges in a range of areas of labeling development, data and compliance.

Color Label Printing At Your Fingertips

By Vince Postil The idea of color printing labels on demand has been thrown around the medical device and pharmaceutical market for many years but in reality, most organizations rely on the traditional two-stage color label printing process they know – batch print and over print. But here lays the problem, huge amounts of label stock on the shelf can be costly and quite often wasted.

Clinical Trials: Managing Labeling Approvals with Multi-Language and Multi-Region Regulations

By Mark Cusworth The clinical trial market is not only global, today it touches more markets than ever before. Increasingly, a key component of this is the need to comply with variable local language labeling requirements, not least in the safe distribution of medicines for clinical trials. With the global map for clinical studies now extensive, information to support the safe and effectual use of trial medicines must be coherent and understandable to the patients receiving them.