Medical devices
Compliant labeling that transforms your business
Medical device manufacturers are facing increasing regulatory pressure. The FDA's UDI requirements are well underway in the U.S. and the European Union Medical Device Regulation (EU MDR) is quickly taking shape with similar directives.
NiceLabel offers a next generation label management system that enables UDI compliant labeling and empowers medical device manufacturers (MDMs) to digitally transform their business. By undergoing this transformation, MDMs are able to increase agility while reducing operational costs.
Learn how digitally transforming your business can give you the competitive advantage in a challenging marketplace.
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Medical device manufacturers who have transformed their labeling
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Webinar
Learn what you need to do right now to address upcoming US FDA Class I and EU MDR requirements.
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We partner and integrate with
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Streamline validation and ensure compliance
NiceLabel’s validation acceleration pack (VAP) offers a standardized approach to streamline validation in a regulated environment.
Whether you have an off the shelf solution or configured the Label Management System for your environment, NiceLabel’s validation acceleration pack aligns with FDA and EU regulatory requirements to allow you to easily maintain a validated and compliant labeling solution.
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Digitally transform your operations with NiceLabel
NiceLabel’s label management system, LMS Enterprise, enables you to automate label printing by implementing a standardized integration with ERP, MES and other business systems at each site. By centralizing master data and establishing a single source of truth, you can eliminate manual data entry errors, mislabeling and associated costs.
Integrate label printing with MES and ERP
LMS Enterprise enables medical device manufacturers to use a single software platform for all printing devices and for all packaging and shipping, from primary to tertiary labeling. By digitizing your label production process, you can meet regulatory requirements faster, reduce labor costs, get products to market faster and avoid recalls related to labeling errors. The result will be a more agile manufacturing operation that will enable your company to meet current and future challenges and compete in an increasingly complex market environment.
A document management system that streamlines compliance with regulatory requirements
LMS Enterprise includes a document management system (DMS) that was built for regulatory labeling. It’s a centralized digital label catalog that controls and streamlines label lifecycle management by providing role-based access, document versioning, configurable approval workflows, and electronic records and electronic signatures (ERES) which are necessary to conform to FDA and EU regulations. A graphical “label comparison” tool helps consolidate label template variations and provides added quality assurance.
Electronic records and audit trails that exceed life science regulation requirements
LMS Enterprise provides a comprehensive set of audit trails, including full traceability and visualization of every printed label. Traceability extends beyond printing to include every change request and system event, including user, location and timestamp information. Additionally, electronic PDF documents reflecting physically printed labels, can be natively generated for submission to 3rd party content management or PLM solutions.
Approve labels for every SKU and avoid creating many label templates
NiceLabel’s label variant technology enables life sciences companies to approve each and every label that is created, down to the SKU level. NiceLabel integrates with your master label data for each SKU and merges it with templates in real time, creating a snapshot of “print compliant labels” that are ready for approval. You approve every label variant for every SKU without having to manually create hundreds or thousands of label variations. Control over label templates results in compliant labels, less label change requests and reduced quality control costs.
Manage label data to reduce quality control costs
Our label management system helps you manage, or even create your master data. You can rapidly configure a data management application with minimal or no coding. The application can manage data from multiple sources and you can easily set up business rules that will automatically select the right data, label template and printer required for your business process. Control over label data results in a streamlined labeling process, compliant labels, less label change requests and reduced quality control costs.
Change and transport system built for life sciences
LMS Enterprise fits seamlessly into the typical, multi-tier IT landscape of medical device manufacturers and includes a change and transport system for controlled and streamlined promotion of changes through different environments like development, quality assurance and production.
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Case study
How LiNA Medical used UDI compliance as an opportunity to digitally transform their labeling
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Digitally transform your labeling processes to capitalize on market opportunities
By digitally transforming your processes with the NiceLabel Label Management System (LMS Enterprise), you will:
- Reduce operating costs: less quarantine, less rework, less recalls and happier customers.
- Achieve quicker time-to-market: business users are empowered to respond to controlled label change requests without IT assistance.
- Increase productivity & reliability: remove manual tasks, streamline label lifecycle management and increase transparency of your labeling process in order to create a more effective and robust supply chain.
- Strengthen collaboration and compliance: gain competitive advantage by digitizing and standardizing your label process, ensuring compliance and quality across teams, sites and external partners.
We're here to help you transform your labeling
The NiceLabel Label Management System has the option to be configured and deployed via a professional services group (PSG) to speed up deployment and ensure that the system is implemented according to best practices. The PSG team can provide IQ, OQ and PQ validation packages and services to help meet your documentation needs and regulatory requirements.
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Learn more about medical device manufacturing’s digital transformation
Case Study
Medical device company achieves global UDI compliance while improving accuracy and reducing costs
Case Study
Global dental device manufacturer achieves compliant UDI labeling and Oracle integration
Blog post
How a small-medium sized medical device company responded to the new regulations
