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Best Practice Guidance for UDI Compliance – published in Med-Tech Innovation

By Warren Stacey The system means that by 2020 most medical devices will need to include a Unique Device Identifier (UDI) in human and machine-readable form. In addition, device labellers must submit mandatory data about each device to the FDA/National Library of Medicine’s Global Unique Device Identification Database (GUDID), enabling the public and healthcare stakeholders to access and download device information. READ THE FULL ARTICLE HERE PAGE 24/25  

Labelling Matters

By Mark Cusworth While not front of mind in drug development, the packaging and, in particular, labelling of medicines are the final pieces of the puzzle. Inaccessible products can have serious implications on patient adherence, costing the industry billions.

A Surprise Package

By Mark Cusworth As global healthcare grapples with the problem of medication adherence, C Everett Koop’s famous observation has become a familiar retort: “Drugs don’t work in patients who don’t take them”. The same concept applies in clinical trials; they are often unsuccessful when patients do not comply with their medication regimes. Furthermore, if the cost of recruiting patients to studies is high, the price of failing to keep them there is even higher.

Develop a Strategy to Ensure Compliant Labeling Inspection

With half of all medical device recalls in recent years caused by packaging and/or labeling errors, it’s time for manufacturers to rethink their approach to labeling inspection.

Compliant Labeling Inspection: Strategies for Success

The continual tightening of regulation around the packaging and labeling of medical devices has so far failed to stimulate a transformation of labeling infrastructure and approach among global device manufacturers. Understandable concerns about the cost and consistency of new technologies has convinced many companies to maintain traditional methods of labeling inspection –

Labelling compliance – what you need to know

In September 2013, the FDA set out its framework for establishing a unique device identification system to identify medical devices through their distribution and use.

Examination of UDI Implementation and Lessons for Manufacturers of Class II Devices

Almost two and a half years after the FDA issued its final rule on a Unique Device Identification system, the clock is ticking relentlessly towards the next critical deadline in the timetable for its compulsory introduction. By September 2016, the labels and packages of all Class II medical devices must bear a Unique Device Identifier (UDI) – and data for such devices must be submitted to the FDA’s Global Unique Device Identification Database (GUDID). The implications for medical device companies are significant.

Our UDI opinion article was published by PMPS

In September 2013, the FDA set out its framework for establishing a unique device identification system to track medical devices through their distribution and use. The system, which is being phased over several years, means that by 2020 most medical devices will need to include a unique device identifier (UDI) in human- and machine-readable form.

Prisym ID to Attend Informa's Pharmaceutical and Medical Device Labelling Summit

PRISYM ID, the leading provider of labeling solutions for the medical device and life sciences industries, is exhibiting on Stand 6 at the Informa Pharmaceutical Labeling Conference. The event takes place between the 27th and 28th October 2015 at the Maritim ProArte Hotel Berlin, Germany.

PRISYM ID is silver sponsor and speaker at medical device labelling conference

PRISYM ID, one of the leading providers of complete labelling solutions for the medical device and life sciences market, is silver sponsor at the third Annual Medical Device Global Labelling Strategies Conference, August 12-13, 2015.

PRISYM ID Named Silver Sponsor and Speaker at 2015 Medical Device Global Labeling Strategies Conference

PRISYM ID, a provider of labeling solutions for the medical device and life sciences market, has been named a silver sponsor at the third annual Medical Device Global Labeling Strategies Conference from Aug. 12-13. The two-day event is held at Double Tree, Hilton Hotel in St. Paul, MN.

PRISYM ID appoints Mike Smith as USA SVP of global operations

PRISYM ID, a leading provider of labelling solutions for the medical device and life sciences industries, has appointed Mike Smith as senior vice president of global operations.

FDA Website Tracks IDs of Medical Devices

The implications of product recall are well understood, and they serve as an operational driver for a change of approach. But the latest FDA announcement that its online Global Unique Device Identification Database, AccessGUDID, is now available to the public and brings the labeling of medical devices under unprecedented levels of scrutiny – with ramifications not only for manufacturers, but also throughout the entire supply chain.  

Keeping Up With the New Medical Device Labeling Requirements in the US

Following the Food and Drug Administration's first compliance deadline last September for medical device makers to start labeling their products with a unique device identifier, many manufacturers will have been persuaded to review their current labeling capabilities. Achieving zero defect labels is not a "mission impossible", says PRISYM ID's Dave Taylor.

The Proposal: Making a Commitment to Labeling

Label lifecycle management is a strategic consideration that has ramifications right across the supply chain. Finding the right partner is the key to long-term success – and it’s all about the proposal. Read the full article here

Exploit Opportunities Offered by UDI Initiative

Sep. 24 saw the first UDI compliance deadline which means that organizations should now be focusing on the implementation phase, following a thorough preparation phase reviewing all current processes and systems in place.

Survey reveals 40% of medical device companies do not have a solution in place for labeling and packaging issues

A recent survey of medical companies in Europe and North America has identified some of the key issues for packaging and labeling operations in the complex and changing medical device market.

Label Defects Top List of Packaging Concerns for Med Devices

A survey, carried out by PRISYM ID, a leading provider of global label lifecycle management solutions for the medical device and life sciences industries, identified label defect control as one of the top issues currently facing almost 40% of medical device and pharmaceutical companies.

Survey: UDI Compliance Poses Significant Challenge

A recent survey of medical companies in Europe and North America has identified some of the key issues for packaging and labeling operations in the complex and changing medical device market.

Medical Design Technology - Ramifications of UDI Requirements

The phased introduction of Unique Device Identification (UDI) requirements in the US means that the labeling of medical devices faces unprecedented scrutiny – with ramifications not only for manufacturers but also throughout the entire supply chain.          

Medical Device and Diagnostic Industry > Label Lifecycle Management

Warren Ward-Stacey comments on how proactive medical device companies are taking a more strategic approach to the management of data by implementing fully integrated, end-to-end label life cycle management systems that capture, store, and disseminate data safely, quickly, and accurately.        

EPM - Talking Point

EPM - Talking Point

Dave Taylor discusses how clinical trial and pharmaceutical manufacturers could perhaps do more to mitigate the risks associated with the local language labeling of clinical trial supplies. If companies are to optimize emerging markets, they must adopt a more uniform approach.          

Medical Design Technology - The War On Error

Product recalls in the medical devices 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. PRISYM ID’s Craig Jones, VP Global Supports Services, outlines how vision systems can help companies eradicate costly and unnecessary labeling defects – and win the War on Error.

EMDT Online - Increasing Operational Efficiency in the Face of UDI: Taking a 360-Degree View

By Warren Ward-Stacey, SVP of Global Sales, PRISYM ID. Increasing operational efficiency whilst ensuring regulatory compliance is a primary aim for all medical device manufacturers and is a driver for change in many organizations. And whilst the last few years have seen some companies recognize the commercial benefits of introducing scalable technology solutions, others remain on the lower rungs of the evolutionary ladder. .        

Medical Design Technology - China in Your Hands: Grasping the Potential of Emerging Markets

By Vince Postill, SVP of Global Business Development, PRISYM ID. In 2011, China officially became the third biggest pharmaceutical market in the world – almost 50% bigger than fourth-placed Germany. Brazil, meanwhile, overtook mature European markets such as the UK, Italy and Spain, to climb to sixth place with 2011 sales of $27.7 billion. And it’s forecast to double in size by 2016.      

International Clinical Trials Magazine - Mind Your Lanugage

International Clinical Trials Magazine - Mind Your Lanugage

Vince Postill, PRISYM ID. The industry’s inconsistent and costly approach to managing local language data and label/booklet design is no longer sustainable – an integrated label lifecycle system would usher in operational benefi ts and improve country-specific designs. The question of how pharmaceutical R&D and clinical supplies organisations control source data for local languages is currently one of the biggest issues facing clinical trial labelling and packaging.

Medical Design Technology - Data Driven Labeling Solution Promises Revolution in Label Lifecycle Management

Medical Design Technology - Data Driven Labeling Solution Promises Revolution in Label Lifecycle Management

PRISYM ID has launched a revolutionary new solution – PRISYM 360, to transform global Label Lifecycle Management in the medical device industry through intelligent use of data. The launch follows a comprehensive customer engagement exercise between PRISYM ID and medical device manufacturing stakeholders – and is a focused direct response to the growing number of significant exposures and challenges that companies in the sector are facing.

European Medical Device Technology - Think Data, Not Labelling

European Medical Device Technology - Think Data, Not Labelling

By Dave Taylor, PRISYM ID - Mislabelling can have severe consequences for a medical device company. But the label itself is not the challenge; manufacturers need to focus on managing the data that surround the label. Given the high percentage of voluntary recalls of medical devices caused by labelling and packaging defects, it’s easy to see why companies focus so much individual attention on the label as part of the production process. 

News Medical - PRISYM ID releases new web-based solution to transform Label Lifecycle Management

News Medical - PRISYM ID releases new web-based solution to transform Label Lifecycle Management

PRISYM ID has launched a new solution – PRISYM 360, to transform global Label Lifecycle Management in the medical device industry through intelligent use of data. The launch follows a comprehensive customer engagement exercise between PRISYM ID and medical device manufacturing stakeholders – and is a focused direct response to the number of exposures and challenges that companies in the sector are facing.

Medical Packaging Innovation - Is 'Just in Time' a Just Approach to Driving Efficiencies?

Medical Packaging Innovation - Is 'Just in Time' a Just Approach to Driving Efficiencies?

PRISYM ID explores the benefits of just in time labeling. Medical device companies are fully aware of the importance of labeling as part of the production process, but they are also aware of how costly it can be. Traditionally, the industry has relied heavily on using pre-printed labels. For most organizations, it's the way it's always been done.

Medtech Insider - Print and Hope Is Not an Effective Strategy for Medical Device Labelling Compliance

Medtech Insider - Print and Hope Is Not an Effective Strategy for Medical Device Labeling Compliance

Guest blog from Warren Ward-Stacey, PRISYM ID: For medical device manufacturers, ensuring accurate and consistent product labeling remains a challenge. From compliance demands for a design-to-print audit log to the complex mix of variable bar codes, images and text required on each label, the process is demanding. Yet the vast majority of companies still use some form of manual checking, if they are checking at all.

MDT - Bringing Medical Product Labeling up to Standard

Medical Design Technology Magazine - Bringing Medical Product Labeling up to Standard

Warren Ward-Stacey, SVP Global Sales, Prisym ID, insists it is time for medical device companies of every size to accept the next regulatory era and put in place robust, highly integrated processes for printing and verifying label creation that minimize the risk of compliance failure whilst also providing the required complete lifecycle audit.

Stamping out counterfeits

Manufacturing Chemist Magazine - Stamping out counterfeits

As efforts to prevent counterfeit drugs become more global and co-ordinated, Vince Postill, VP of Business Development, PRISYM ID explains the role of serialisation and the main technological approaches.

Bringing Medical Product Labeling up to Standard

European Medical Device Technology Magazine - Bringing Medical Product Labeling up to Standard

In the current regulatory environment, with agencies such as US FDA demanding complete lifecycle traceability of every product, accurate labelling is a necessity. It is time for medical device companies of every size to accept the next regulatory era and put in place robust, highly integrated processes for printing and verifying label creation that minimise the risk of compliance failure whilst also providing the required complete lifecycle audit.