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By Marcelo Trevino, independent expert
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The European Commission's simplification package is being debated almost entirely as an MDR story. The IVDR provisions carry the same legal force, and the window to shape them closes this fall.
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What Factors Impact Quality For Medical Device Manufacturers?
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Q&A | Pharma & MedTech Partner Division, B. Braun Medical Inc.
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This article asks Corporate Vice President of Quality at B. Braun Medical Inc. about how quality is impacted in medical device companies by FDA regulations, collected data, and more.
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Medical OEMs need a manufacturing partner that delivers technical expertise, responsiveness, quality, accountability, and scalability from development through production.
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Early decisions can help medical OEMs reduce validation risk, improve manufacturability, strengthen process readiness, and avoid costly late-stage changes.
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