The Global Harmonization Task Force (GHTF), an international harmonization body whose duties are soon to be subsumed by the International Medical Devices Regulators' Forum (IMDRF), has released a ...

Professional services consultancy, Procorre is urging the Medical Devices industry to take action ahead of the new ISO13485:2016 International Standard and MDD & IVD ‘Recast’ which become mandatory in ...

The global In-Vitro Diagnostics (IVDs) Medical Device Market was valued at approximately USD 86 billion in 2024 and is projected to reach USD 135 billion by 2034, growing at a CAGR of 4.8% over the ...

HiMedia is dedicated to maintaining high safety, quality, and performance standards for in-vitro diagnostic products used in healthcare. This commitment significantly enhances the well-being of ...

At this year’s MEDICA convention in Düsseldorf, Germany, innovation across the medical device and IVD industries was on full ...

Collaboration focuses on blood filters, leukoreduction, cleanroom assembly, and disposable medical manufacturing in ISO 7 & ISO 8 cleanrooms. By working with THY Precision (Hong Yang Precision), we ...

Following their adoption by the European Parliament in April 2017, the final versions of the Medical Devices Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR") were published in the ...

Medical device regulators launched new initiatives on harmonizing in vitro diagnostic (IVD) regulations and tweaking the Medical Device Single Review Program (MDSAP) for additional countries to ...

This article is the third in Microbiologics’ series on Optimal QC in the Clinical Laboratory. Previously, in this series we highlighted the importance of external and third-party quality control ...

Dublin, Nov. 13, 2020 (GLOBE NEWSWIRE) -- The "Medical Device & IVD Regulatory Affairs Outsourcing Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2020 - 2030" report has ...

Ophthalmic Devices: This market saw imports accelerate dramatically, growing 49.0% in 2024 to reach $1.14 billion. This is fueled by an aging population, a high prevalence of diabetes-related eye ...