Blogs

Medical Device What is FDA 21 CFR PART 11 Posted in: Blog, Business Analysis, Medical Device, Regulatory & Compliance - FDA 21 CFR Part 11 allows Medical Device and Life Science organizations to use electronic records and signatures in place…
EUROPEAN MEDICAL 300x225 - What is the European Medical Device Regulation – EU MDR? What is the European Medical Device Regulation – EU MDR? Posted in: Blog, Medical Device, Regulatory & Compliance - The European Medical Device Regulation (EU MDR) ensures high standards of quality and safety for medical devices being produced in…
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Medical Device UDI: FDA Draft Guidance Posted in: Achieving Regulatory Compliance, Blog, Business Analysis, Medical Device, Operations & Labeling, Regulatory & Compliance - The US Food and Drug Administration (FDA) published its latest draft guidance on UDI, entitled: “Unique Device Identification System: Form…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…
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