Clinical Trials: Managing Labeling Approvals with Multi-Language and Multi-Region Regulations

Now more than ever, the clinical trials’ landscape touches more regions than ever before. As a result, new studies are grappling with the challenge of managing variable local language labeling requirements.  Read More

Mission Possible; Streamlining Label Validation

For many years, validating labeling processes has felt like an impossible mission for global medical device manufacturers, and has in some ways become a major barrier to the deployment of new systems for the fear of lengthy testing cycles and spiraling costs. Yet Label Lifecycle Management (LLM) is a mission critical ‘must have’ for life sciences organization that need to streamline processes, reduce labeling errors and mitigate risk.

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‘Labeling Trends’ Blog Series #3 Keeping the FDA from your Door – Ensuring Regulatory Compliance

In a recent survey, 43% of responders were not confident or were unsure as to whether their current labeling solution would do everything required beyond 2015. With regulations such as 21 CFR Part 11 to comply to and others coming to fruition including FDA UDI, medical device manufacturers whether large or small need to be change. Read More

‘Labeling Trends’ Blog Series #2 Playing a Tactical Game – Efficiencies through Labeling Postponement

Labeling as part of the supply chain is a costly business for medical device companies. With the bottom-line being a priority for any organization, seeking areas to deliver better efficiencies is key. Yet finding those hidden gems isn’t always easy, even when it’s under our noses.Labeling postponement may be one such gem. Read More

‘Labeling Trends’ Blog Series #1 The Data Management Headache

Never has the integrity of medical device labels been so scrutinized. As medical care evolves and the devices used become more refined, organizations need to uniquely identify devices to prevent adverse events occurring. Read More

[BLOG SERIES] 7 Labeling Pain Points and How to Overcome Them

For any business, managing change is a constant challenge. This is particularly true in life science industries where regulatory changes and supply chain efficiencies are ever present and constantly evolving. Read More