EU MDR: Innovating for Enhanced Patient Safety
The intricate challenges, emerging trends, and transformative technologies that are shaping the future of regulatory compliance.
Read ArticleIntroduction
Medical device recalls due to mislabeling and packaging errors are the cause of some major problems in the industry. Manufacturers are implementing measures to cope with constantly amending regulatory requirements for medical device packaging & labeling in major geographies.
As the MedTech industry is consolidating with a greater number of M&As, manufacturers are additionally investing in rebranding, centralizing their enterprise systems, and standardizing their labeling lifecycle. Moreover, medical device manufacturers are exploring sustainable packaging solutions to tackle biomedical waste rampant across the industry.
Driving QARA Programs through a Global Engineering Network
Here's How We Help
Cross-functional collaboration to cope with evolving regulatory landscape
- Interdisciplinary expertise (regulatory, packaging, & labeling), testing infrastructure, & ready-to-use customizable assets for accelerated remediation
- Centralized project management ensuring accuracy & integrity of labels across the supply chain
Standardize & automate labeling workflow across multiple manufacturing sites
- Harmonize labeling processes to reduce turnaround time & increase output efficiency
- Increase agility to save significant cost associated with a product launch, rebranding, & recalls due to mislabeling
Sustainable packaging solutions that demonstrate sterile barrier properties
- Design & development of sterile packaging & aseptic presentation in compliance with ISO 11607-1 & ISO 11607-2
Solution Framework
Why Tata Elxsi?
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End-to-end service portfolio from identifying and adopting the right enterprise LMS, validating the implementation to label creation and verification
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Extensive expertise on tools such as Solidworks, Catia, ArtiosCAD, Prisym, Bartender, Label Vision, etc.
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Strategies for optimizing additional packaging tests through robust rationales
Information Hub
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What are best practices for medical device packaging and labeling?
Medical device packaging and labeling must protect product integrity, ensure sterility, and communicate essential safety information clearly. Compliance with global standards like ISO 11607 and UDI requirements is vital for traceability and regulatory approval. Incorporating human factors engineering, robust validations, and region-specific labeling reduces errors and recalls. Thoughtful packaging and labeling strategies support supply chain efficiency and safeguard patients across diverse healthcare environments, enhancing overall device performance and trust.
