Regulatory Articles
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Keeping Up With Counterfeiters: The Battle Against Counterfeit Medical Devices
4/29/2019
Steve Ellison, PRISYM ID, examines the battle against counterfeit medical devices.
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EU MDR Does Not Draw Distinctions
4/29/2019
Mark Cusworth, VP of Research and Development at PRISYM ID, examines The ten steps to labeling implementation for both SMEs and large enterprises.
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EU MDR: Are Your Labels Compliant?
4/29/2019
Mark Cusworth, VP of Research and Development at PRISYM ID examines the EU Medical Device Regulation and its implications on labeling, and looks ahead to the future and the predicament companies will begin to face unless they start to make changes now.
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Improving Global Labeling Workflow
4/29/2019
One of the leading suppliers of medical devices to the orthopedic market has been working with label lifecycle management solution provider, PRISYM ID to help implement a compliant label solution with validated label processes for its product portfolio. The company manufactures and delivers products with a wide range of capabilities including joint replacements, spine and micro implant systems, orthobiologics, powered surgical instruments, surgical navigation systems, endoscopic products as well as patient handling and emergency medical equipment. After looking at the company’s requirements, PRISYM ID implemented a solution to ensure regulatory compliance and the automation of the labeling functions.
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EU Medical Device Regulation (MDR): The Useful Guide To Labeling Compliance
4/24/2019
Compared to the previous European Regulation MDD, the new EU MDR/EU IVDR offer a change from the pre-approval stage to a life-cycle approach. One of the new aspects of the legislation is the introduction of Unique Device Identifiers (UDI) to products, allowing the ability to trace a device from its manufacturer through the supply chain to the final end user. Whether 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 new EU MDR/EU IVDR. This article offers useful guidelines for adhering to the new EU MDR/EU IVDR.
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OriGen Biomedical Implements PRISYM ID’S Cloud Based Labeling Solution To Automate Processes And Achieve Regulatory Compliance
4/24/2019
OriGen Biomedical is a leading producer of cryopreservation, cell culture, and ECMO respiratory products. Their focus is to produce a range of products to support the treatment of respiratory distress, cancer, genetic conditions, and other life-threatening diseases. OriGen Biomedical depended on a manual solution for managing labeling for their products, but it was vital for a new solution to be easy to implement, comprehend, and use and to enable rapid deployment to market for new products. The PRISYM SaaS was selected due to its compliance-first approach and it being hosted within a cloud environment exclusive to life sciences organizations, facilitating speedy implementation.
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The Useful Guide To Unique Device Identification
4/24/2019
For the sake of patient safety, the ability to track and trace medical devices at a global level is paramount. However, there are some key considerations to be aware of when implementing Unique Device Identification (UDI). This article offers guidance on the use of UDI and what its benefits are.
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Medical Device Label: Before And After EU MDR/IVDR
4/24/2019
EU MDR introduces additional information that needs to be included on labels, forcing organizations to design new label templates that make room for data not previously part of the labeling system. It’s both a design and a data challenge, and they must quickly be addressed to avoid a sticky situation.
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PRISYM SaaS: A Compliance Ready Solution For Small To Medium Medical Device Organizations
4/24/2019
The burden of meeting FDA requirements is often most acutely felt in small to medium-sized organizations that do not have the resources to implement the type of enterprise label lifecycle management solution that can automate much of the compliance process and reduce the load.
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Barcode Considerations For Medical Device Labeling
4/24/2019
Barcodes labeling and packing are a critical part of the life sciences and medical devices products. But how do you know that your barcode and packaging design surrounding it meets what is required? This article presents a number of considerations for the use of barcodes in medical device labeling.