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3254 results found
When an IDMC Needs More than the Planned Data Package
Learn how biostatistics supports IDMC review with validated outputs, patient-level context, live data clarification and controlled handling of unblinded trial data.
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What is ISO 13485? An easy-to-understand guide to preparing for the medical device standard.
ISO 13485 is a quality management system standard for the medical device industry, helping organizations manage quality, reduce risk, meet regulatory expectations, and prepare for certification in domestic and global markets.
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Advancing Safer Chemistry Through Project DW(O)R‐X
Through Project DW(O)R‑X with Fashion for Good, we are delivering real‑world performance benchmarking to support safer alternatives to PFAS for the softlines industry.
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IVDR Bottleneck: A Key Challenge for the IVD Industry in Europe
Learn what the IVDR bottleneck is, why certification delays are affecting the European IVD industry, and how manufacturers can improve IVDR compliance through proper classification, Notified Body planning, and EUDAMED readiness.
Georgia Phases in Restrictions on Specified Disposable Food Contact Plastics
Enforcement dates revised for single-use plastic food containers and cups in Georgia, with restrictions phased in during 2027.
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Ecuador Consults on Updated Draft Technical Regulation for Certain Food Contact Articles
Ecuador proposes updated requirements for food contact glass, ceramic and glass-ceramic articles.
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US Legislative Developments: Prohibition of Chemicals in Food Contact Materials
US introduces two proposals to regulate specified chemicals in food contact materials (FCMs) and articles.
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FAQ: What You Need to Know About the EU Packaging and Packaging Waste Regulation (PPWR)
A practical guide to PPWR requirements, timelines and compliance steps for packaging across the EU market.
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Notified Body Status Under EU Battery Regulation (EU) 2023/1542 for Finland
Our team in Helsinki, SGS Fimko Oy, has received Notified Body status for conformity assessment services under the EU Battery Regulation (EU) 2023/1542.
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Montenegro Issues New Framework Regulation for Food Contact Materials
Montenegro introduces EU-aligned requirements for food contact materials (FCMs) and articles.
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