Medical Device

The Challenges In Medical device Labeling

Medical Device manufacture represents one of the most demanding of labeling operations of any industry.

Each Regulatory Authority specifies an extensive amount of content that must be present on every device’s labeling and Instructions for Use (IFU). This varies by country and device-type, creating a content control challenge that ERP systems and enterprise labeling applications simply cannot address.

As both product specifications and country-specific regulations change, assuring on-going label quality and compliance represents a clear operational risk. Delays in label design and approval can impact production, whilst any errors may result in CAPA incidents, product recalls or ultimately affect patient safety.

HOW WE HELP

PRISYM 360 delivers innovative label and content management features which incorporate industry best practices, designed specifically to meet the complex regulatory requirements of medical device labeling.

Mass change functionality, Regulatory Rules, phrase and language management and Adobe InDesign artwork management features enable labels and IFUs to be created or updated quickly and accurately, whilst Approvals workflows streamline and record the content approval process.

PRISYM 360’s Medical Device specific print processes facilitate a diverse range of production models including batch, print-on-demand and unattended print, whilst PRISYM ID’s unique Automated Vision print inspection provides quality assurance by capturing and reporting content print errors in real-time.

PRISYM ID’s unique content management features and best practice functionality for creating, changing and printing medical device labels and IFUs provide the continued assurance of label quality and compliance.

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OUR UNIQUE SOLUTIONS FOR MEDICAL DEVICE LABELING

MANAGING MASS CHANGE EVENTS

Mass Change - Medical Device

When a logo, product name or compliance statement used in Medical Device labels or IFUs needs to change, finding all the places where it is used, and then performing updates, can prove a significant administrative activity.

As PRISYM 360 keeps track of the usage links between content, it can quickly provide details of the labels or multi-page documents that make use of certain content, such as specific images or phrases. Searching on content components will provide results in either a detailed table or in a graphical relationship view. Change request and version control tools help automate the process for managing the content change, whilst ensuring compliance and reducing risk associated with the change event.

MEDICAL DEVICE IFU AND ARTWORK DESIGN

Artwork IFU - Medical Device

Medical Device packaging artwork and IFU inserts comprise increasingly significant amounts of regulated content, which is often manually entered by artwork designers.

This lack of content control increases the amount of errors, which correspondingly extends review and approval cycles.

PRISYM 360 provides designers with real-time access to product specific, approved content within Adobe InDesign, to create compliant artwork. This approach reduces the risk of errors being introduced during artwork creation, thereby minimizes the effort required for review and approval.

MEDICAL DEVICE LABEL PRINT INSPECTION

Print Inspection - Medical Device

FDA labeling regulations require medical device labels are inspected for errors, but manual visual inspection of printed labels is laborious, costly and error prone. Print inspection technology should help, but is difficult to set-up, and creates an operational overhead of running two systems, labeling and print inspection.

By knowing the label’s design and content, PRISYM 360’s fully integrated Vision print inspection simplifies and automates real-time inspection on both the content and design of every printed label. This minimizes effort in inspection setup and operation and identifies more errors at time of print.

Forthcoming Regulatory Changes

The Clock is Reset…Opportunity for your Organization to Re-Evaluate Compliance to EU MDR Labeling

A webinar from the experts at KPMG & PRISYM ID on meeting the updated timelines for EU MDR

COVID-19, social distancing measures and the obligation felt by the medical device industry to prioritize response efforts and reduce any production shortages of necessary supplies to battle this global pandemic, has resulted in the European Parliament voting to delay the implementation of the EU MDR regulation. The European Parliament has officially provided medical device organizations a 12-month reprieve on the European Medical Device Regulation (EU MDR) thus allowing companies the ability and most importantly time in getting their houses in order.

In this webcast, Vishal Pathak, Life Sciences Advisory Manager, Richard Castle, Global Sales Manager Medical Devices at PRISYM ID and Kevin Grygiel, VP Strategic Accounts & Partner Ecosystem at PRISYM ID will delve deeper into the impact of changed EU-MDR timelines and key insights into how the medical device industry will meet labeling and packaging compliance from a Global perspective

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