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One Year Is Not Enough to Harmonize Quality Systems with ISO 13485

One Year Is Not Enough to Harmonize Quality Systems with ISO 13485

by Glenn S. Demby | Mar 17, 2022 | Articles, Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

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Cerba Research Unifies Quality Processes with Veeva Vault Quality Suite

Cerba Research Unifies Quality Processes with Veeva Vault Quality Suite

by Veeva Systems | Mar 1, 2022 | Articles, News, Open Content

BARCELONA, SPAIN — Veeva Systems announced March 1 that Cerba Research selected Veeva Vault Quality Suite to strengthen its laboratory and testing operations. With Vault Quality Suite, the company will advance quality for greater efficiency and compliance across its...
Harmonizing Device CGMP Requirements with International Standards

Harmonizing Device CGMP Requirements with International Standards

by Glenn S. Demby | Mar 1, 2022 | Articles, Essential, FDA-lir, Laboratory Industry Report

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Leader in Brain Health Sector Achieves Key Certification

Leader in Brain Health Sector Achieves Key Certification

by C2N Diagnostics | Feb 22, 2022 | Articles, News, Open Content

ST. LOUIS, MO — C2N Diagnostics has earned ISO 13485:2016 certification for its quality management system. In late 2020 C2N launched the PrecivityAD™ test, an innovative blood test intended for use with patients with cognitive impairment. The test aims to help health...
Medicare Reimbursement: MIPS Bonuses Are Easy to Earn, IF You Can Get into the Program

Medicare Reimbursement: MIPS Bonuses Are Easy to Earn, IF You Can Get into the Program

by Glenn S. Demby | Sep 23, 2019 | Essential, Lab Compliance Advisor, News at a Glance-lca, Reimbursement-lca

From - Lab Compliance Advisor
On July 11, CMS announced the results of 2018, Year 2 under the Merit-based Incentive Payment System…


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