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Standards

USA and EUROPE Looking Ahead to 2020

FDA Issues Guidances on Dual 510(k) and CLIA Waiver Applications

FDA Launches New Interactive 510(k) Template Program

USA: FDA Drafts Guidance on Bridging Data for Combination Products

IMDRF Offers Final Clinical Guidelines

South Africa released Guidelines – How to Submit EOI to SAHPRA on WHO Collaborative Registration Procedure

The First Step

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