UDI: An inconvenience or a chance for change? Posted in: Achieving Regulatory Compliance, Blog, Business Analysis, Increasing The Operational Efficiency, Information Technology, Medical Device, Operations & Labeling, Overcoming The Technical Challenges, Project Managers, Regulatory & Compliance - It’s nearly three years since the original publication of UDI and the industry is well on track to achieving compliance.… Labeling Trends Blog Series #4 Global Standardization – Embracing the ‘Orphaned’ Business Function Posted in: Blog, Business Analysis, Clinical Trials, Increasing The Operational Efficiency, Information Technology, Medical Device, Operations & Labeling, Pharmaceuticals - Label Lifecycle Management (LLM) is mission critical for global device manufacturers – if labels cannot be printed accurately, a product… Mission Possible; Streamlining Label Validation Posted in: Achieving Regulatory Compliance, Blog, Increasing The Operational Efficiency, Information Technology, Medical Device, Operations & Labeling, Overcoming The Technical Challenges, Project Managers, Regulatory & Compliance, Supply Chain - For many years, validating labeling processes has felt like an impossible mission for global medical device manufacturers, and has in… ‘Labeling Trends’ Blog Series #3 Keeping the FDA from your Door – Ensuring Regulatory Compliance Posted in: Achieving Regulatory Compliance, Blog, Business Analysis, Medical Device, Operations & Labeling, Project Managers, Reducing Risks, Regulatory & Compliance, Supply Chain - In a recent survey, 43% of responders were not confident or were unsure as to whether their current labeling solution… FDA launches website to track medical devices with IDs Posted in: Achieving Regulatory Compliance, Blog, Medical Device, Regulatory & Compliance - The implications of product recall are well understood, and they serve as an operational driver for a change of approach.… ‘Labeling Trends’ Blog Series #2 Playing a Tactical Game – Efficiencies through Labeling Postponement Posted in: Achieving Regulatory Compliance, Blog, Medical Device - Labeling as part of the supply chain is a costly business for medical device companies. With the bottom-line being a… ‘Labeling Trends’ Blog Series #1 The Data Management Headache Posted in: Achieving Regulatory Compliance, Blog, Business Analysis, Information Technology, Medical Device, Operations & Labeling, Overcoming The Technical Challenges, Project Managers, Reducing Risks - Never has the integrity of medical device labels been so scrutinized. As medical care evolves and the devices used become… [BLOG SERIES] 7 Labeling Pain Points and How to Overcome Them Posted in: Achieving Regulatory Compliance, Assisting With The Consolidation, Blog, Business Analysis, Clinical Trials, Enabling the Expansion, Increasing The Operational Efficiency, Information Technology, Medical Device, Operations & Labeling, Overcoming The Technical Challenges, Pharmaceuticals, Project Managers, Reducing Risks, Regulatory & Compliance, Supply Chain - For any business, managing change is a constant challenge. This is particularly true in life science industries where regulatory changes… ‘Labeling Challenges’ Blog Series, Issue #7 Three key considerations for implementing UDI Posted in: Achieving Regulatory Compliance, Blog, Business Analysis, Medical Device, Operations & Labeling, Regulatory & Compliance - In the ever increasing interests of patient safety and efficient protection of public health, the FDA has adopted a rule… ‘Labeling Challenges’ Blog Series, Issue #6 The 3 C’s of Label Production Posted in: Blog - Recent UDI requirements have persuaded many medical device companies to review their labeling capabilities. This, alongside other regulatory, technological and…