We help medical device manufacturers of any size to safeguard their reputation by ensuring FDA & EU compliance, minimizing risks and reducing costs by eliminating labeling recalls.
Our labeling solutions are scalable and were designed by the market for the market. We successfully delivered more implementations than our competitors all together.
Our configurable applications - designed in conjunction with industry leaders and customer user groups including Boston Scientific, Zimmer, and Stryker - address both today’s challenges and tomorrow’s business needs.
Labeling errors are a recurring reality for medical devices. Companies’ continued reliance on manual processes and incongruent labeling systems often results in pricey product recalls. As label content becomes more complex with the introduction of new regulations, costs to change global labels will increase if companies don’t proactively review and strengthen their labeling infrastructure. This eBook discusses the four most common scenarios in recalling labeled medical device products and solutions for each of them.
There is only one labeling solution dedicated to the medical device industry. Delivered by a true Labeling Market Leader.
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.
Boston Scientific, one of the world’s largest medical device manufacturers, was looking to standardize on a single labeling system. The project initially arose when a worldwide branding exercise highlighted the huge variances in label formats and styles on secondary packaging; standardizing on a single labeling system would offer consistency, increase efficiency and compliance.
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.
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.
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.
Companies’ continued reliance on manual processes and disparate labeling systems often culminates in pricey product recalls. In 2018, nine percent of all medical device recall events – and the return of over a million units – were due to labeling issues.
Mark Cusworth, VP of Research and Development at PRISYM ID, examines The ten steps to labeling implementation for both SMEs and large enterprises.
Steve Ellison, PRISYM ID, examines the battle against counterfeit medical devices.
Warren Stacey, PRISYM ID, examines a single-source approach that could eradicate data duplication, inconsistencies, and costly human error.
Many companies are using the “Touch once” terminology to address the concerns of EU MDR and also the fact that the platforms that their labeling solution sits on and is validated against will be unsupported (depending on the platform) between 2020 and 2022. Labeling systems need to be compliant with EU MDR by 2020. Ensure you only touch your labels once, while addressing both impending deadlines.
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.
In a recent survey conducted by PRISYM ID, 26% of respondents admitted that they have just started to think about EU MDR, 24% of respondents admitted that they haven’t started to think about EU MDR and 50% of respondents said they understood the implications and plans are in progress. This infographic presents top concerns with regards to EU MDR and what do they think about the areas likely to be affected and about the resources needed to implement the EU MDR.
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. However, for those that aren’t – and indeed those that may have made only basic adjustments to their labeling infrastructure in response to the regulations – there are five key learnings that have emerged from PRISYM ID's UDI experience that may help inform best practice adoption with EU MDR.
Medical device and pharmaceutical organizations are constantly looking at ways to avoid labeling errors which are a major reason for FDA product recalls. In a recent survey conducted by PRISYM ID, 67% of respondents admitted that human error was the most frequent cause for their labeling errors and 45% frequently experienced quality issues throughout their label production process.
The European medical device industry is in the grip of the biggest change the market has seen in decades and the European Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) ensures high standards of quality and safety for medical devices being produced in or supplied into Europe. Whether producing medical devices within Europe or supplying to Europe from the rest of the world, a manufacturer or supplier will need to adhere to the new EU MDR. This white paper presents 10 steps required to make the implementation of EU MDR labeling simpler.
The European medical device industry is a third of the way into a 3-year transitional period that will culminate with full implementation of the EU Medical Device Regulation (EU MDR) in 2020. The new regulation, which entered into force in May 2017, imposes major new rules on companies involved in the design, manufacture, approval and commercialization of devices that are sold in the EU. Will your labeling strategy assure compliance With EU MDR?
The European medical device industry is in the grip of the biggest changes the market has seen in decades. Significant new rules to ensure the safety of medical devices became active in June 2017, imposing major new requirements on anybody involved in the design, manufacture, approval and commercialization of devices that are sold in the EU. As organizations struggle to meet the challenges of EU MDR – which is broader and more complex than UDI regulation – there are many lessons to be learned from that UDI experience. This paper presents those learnings, primarily through the lens of the labeling function, but with an appreciation of the wider context of the full regulations.
Join medical device labeling and data experts from PRISYM ID and Reed Tech to find out the latest recalls trends from the industry, to hear about industry real-life scenarios and see how the right software platforms can help you deliver an effective strategy to minimize the risks of labeling recalls.
Join Intuitive Surgical and PRISYM ID for this 60-minute webinar on how to successfully integrate SAP with your label software to accelerate your business processes through end-to-end automation.
As part of the MedTech Summit Digital Week we are sponsoring and presenting a webinar on EU MDR, featuring two industry experts, Mark Cusworth and Andrew Love.
The cost of making a global label change – using traditional processes built around multiple systems – has historically been expensive. As a result, a growing number of medical device companies are adopting ‘touch once’ strategies where they undergo a wholesale redesign of their global labeling processes all in one go, rather than repeating the cost and disruption of additional change implementations further down the line.
Join medical device labeling and data experts from PRISYM ID and Reed Tech to learn about what the EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) mean for labels in this free webinar.
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