Blogs

Medical Device What is the Unique Device Identification – UDI? Posted in: Blog, Medical Device, Operations & Labeling, Regulatory & Compliance - The FDA’s Unique Device Identification (UDI) of medical devices aims to offer a practical solution to display standard product information…
Medical Device UDI: FDA Draft Guidance Posted in: Achieving Regulatory Compliance, Blog, Business Analysis, Medical Device, Operations & Labeling, Regulatory & Compliance - The US Food and Drug Administration (FDA) published its latest draft guidance on UDI, entitled: “Unique Device Identification System: Form…
Leveraging 300x225 - Leveraging Your Supplier Leveraging Your Supplier Posted in: Achieving Regulatory Compliance, Blog, Business Analysis, Clinical Trials, Medical Device, Operations & Labeling, Project Managers, Reducing Risks, Regulatory & Compliance, Supply Chain - Leveraging your supplier is one of the five key principles of the GAMP 5 ‘Risk-based approach to compliant GxP computerised…
Blog Placeholder 300x225 - FDA Regulations for Inspection FDA Regulations for Inspection Posted in: Achieving Regulatory Compliance, Blog, Medical Device, Operations & Labeling, Regulatory & Compliance - Ignoring the warning signs of non-compliance is no longer an option Data shows that more than half of all FDA…
Blog Placeholder 300x225 - Labeling Trends Blog Series #4  Global Standardization – Embracing the ‘Orphaned’ Business Function 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…
1 2 3 4 5 6