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Marked for Life

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Lasers enable safe, scratch-resistant marking that’s more durable than ever.

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In medical technology, safety is paramount. Every step in the manufacturing process must meet the highest standards, from patient protection to regulatory compliance.

New NIST Reference Strengthens Quality Control for Biological Drugs

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A team of NIST researchers, including Srivalli Telikepalli (shown here), developed a standard reference material that will help biopharmaceutical companies better detect these particles in their drug products.

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A rapidly growing category of drugs called protein-based biotherapeutics can be used to treat cancers and genetic and autoimmune disorders.

Pharmaceutical Serialization

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Pharmaceutical serialization practices are on the rise and have progressively become a worldwide standard as a result of stringent regulations in various of markets, including the United States, European Union, China, and Argentina.

Carrying Out a Supplier Audit

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Good supplier management is one of the most important methods of building a safe and effective medical device.

5 Key Elements of an Effective CAPA System

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The corrective and preventive action (CAPA) process is one of the most important elements within a medtech company’s quality management system (QMS).

How Tech-Enabled Solutions Can Simplify BRCGS Packaging Materials

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A global food safety and quality certification, BRCGS (British Retail Consortium Global Standards) initially focused on food safety but now comprises various sectors such as packaging, co

FDA Guidances on AI-Enabled Devices

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As part of its effort to address the changing landscape around artificial intelligence (AI) in medical devices, the U.S.

How to Avoid FDA Warning Letters

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According to the U.S.

Facing Medtech Uncertainty

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One of the key findings in Greenlight Guru’s 2025 Medical Device Industry Re

2025 Medical Device Industry Report

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The medical device industry is growing. Data from KPMG predict that global annual sales will rise by 5% per year to reach just under $800 billion by 2030.

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