Redefining medical device labeling to meet regulations, control costs, and scale operations in an evolving landscape
100%
W.L. Gore achieves 100% label accuracy
70%
Quest Medical、ラベルの納期を70％短縮
Our goal was to implement an integrated label management process that guaranteed accurate labels and data integrity.
Patrick Taels, ICT Manager at Plastiflex Group
The medical device industry faces complex supply chain challenges that stem from regulatory shifts, fast moving technological advancements, global market dynamics, and evolving healthcare expectations.
To remain competitive and meet these diverse operational hurdles, organizations must focus on product identification. By implementing cloud-based medical label design software, it strengthens traceability, authenticity, and increases connectivity across the supply chain.
Integrate artwork management and label production for medical devices, secondary packaging, and distribution with speed and accuracy
Manage regulations such as FDA 21 CFR Part 11, FDA Unique Device Identification (UDI), and the European Union’s Medical Device Regulations (EU MDR), reducing risks, errors, and fines
Ensure accurate label localization across languages and symbols, meeting evolving global requirements effortlessly
Support UDI requirements, recalls, ECG demands, and waste management
Provide industry-leading documentation, guidance, and support to aid the validation process
Integrate with PLM, MES, and ERP applications as well as any SAP landscape - safeguarding migration to SAP S/4HANA, and supporting supplier/customer connectivity
当社製品
Loftware のバリデーション対応型クラウドラベルソリューションで、コンプライアンスの取り組みを簡素化しましょう。医療機器メーカー専用に設計されたこのソリューションは、規制リスクを軽減し、あらゆる規模の企業において市場投入までの時間を短縮します。
拡張可能なコンプライアンスの確保自動化されたワークフロー、組み込みの承認プロセス、リアルタイムのコラボレーションにより、パッケージングのアートワーク管理を効率化します。Loftware Smartflow を活用して、市場投入までの時間を短縮し、規制遵守を確実なものにします。
Smartflow の実際の動作をご覧ください
Cross-platform integration
Data driven labeling for compliance
Automate translation management
Centralized control for traceability
Leverage business applications & digital technologies
Simplify validation/cloud assurance
Build efficiencies and enable accuracy with end-to-end solutions that share common approved content for labels and packaging - including information for use, UDI data, expiration dates, barcodes, ISO symbols, and images used throughout the product lifecycle.
Seamlessly integrating labels across printers, manufacturing environments, and software systems globally eliminates bottlenecks, streamlining operations and ensures consistent, accurate, and efficient labeling.
We were looking for a state-of-the-art, enterprise-wide labeling solution for all Siemens Healthineers to keep pace with market demands.
Mark Illgner
Senior Labeling Development Engineer
We were able to go from a 30-minute conversation with an auditor about how we can produce a label, to a couple of minutes to log into the system and provide the actual label image to the auditor.
Michael R. Kinnett
Product Labeling, Medical Products Division
We can now ensure global market access for our medical devices and tailor label content as required, leading to faster product approval and reduced regulatory delays.
Mark Illgner
Senior Labeling Development Engineer
Loftware’s Validation Acceleration Pack was a ‘lifesaver’. It gave us the main structure that we needed for external audit reasons to document the system correctly.
Patrick Taels
ICT Manager at Plastiflex Group
Meeting regulatory labeling and identification compliance on a global scale while addressing regional nuances around language and symbologies is challenging.
Medical device manufacturers, co-packers, and suppliers must comply to ensure device integrity, patient safety, market access, and availability worldwide.
Loftware’s solutions ensure you meet requirements, ensuring accuracy at every stage of compliance for standards and regulations including:
Identify and track medical devices throughout their lifecycle to improve product safety and streamlining the healthcare supply chain.
Rules that governs the production and distribution of medical devices within the European Union
Label content and format standards for Canadian market
Labeling requirements for medical devices and pharma products
Country-specific labeling standards for China
Global guidelines for labeling and packaging
