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Medical Device Design Controls: Definition, Requirements, Process, and Phases

Medical Device Design Controls: Definition, Requirements, Process, and Phases Written by Arterex Medical Published on June 26, 2025 Read time 15 minute read Design controls are a systematic set of requirements and procedures that govern the design and development process for medical devices. They form a critical component of the quality management system required by

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what is medical device design and development

What To Know About Medical Device Design and Development?

What To Know About Medical Device Design and Development? Written by Arterex Medical Published on May 12, 2025 Read time 12 minute read Designing and developing a medical device is a highly intricate and regulated process that requires a deep understanding of various disciplines, from engineering and manufacturing to regulatory affairs and quality control. It

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Medical Device Industry Facts, Trends and Statistics 2025

Medical Device Industry Facts, Trends and Statistics 2025 Written by Arterex Medical Published on April 1, 2025 Read time 5 minute read The medical device industry is a cornerstone of global healthcare, offering advanced tools, machinery, and technologies. These tools enable the healthcare industry for better diagnosis, effective treatments, and better patient outcomes. The industry

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Medical device cleanroom classification and requirements

Medical Device Cleanroom Classification and Requirements

Medical Device Cleanroom Classification and Requirements Written by Arterex Medical Published on March 7, 2025 Read time 15 minute read The importance of a controlled environment is crucial in the medical manufacturing industry to adhere to safety and efficient performance and applicable regulations. Clean rooms are important to control these airborne particles and microbes, as

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Arterex Expands Medical Manufacturing, Metal Fabrication, and Machining Capabilities with Acquisition of Adroit USA Inc.

Arterex Announces Acquisition of Adroit USA

Arterex Expands Medical Manufacturing, Metal Fabrication, and Machining Capabilities with Acquisition of Adroit USA Inc. Written by Arterex Medical Published on February 03, 2025 Integration expands Arterex’s platform with additional manufacturing plants in India, strengthening its global footprint in medical device contract manufacturing February 3, 2025 – Arterex, a leading global medical device developer and contract

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Arterex Acquires Phoenix S.r.l. to Expand in European Market

Arterex Announces Acquisition of Phoenix

Arterex Announces Acquisition of Phoenix S.r.l., a leading Italian Medical Device Solution Provider Written by Arterex Medical Published on January 21, 2025 The transaction expands Arterex’s capabilities in medical device development, finished device assembly and packaging to Europe (Arterex, January 21, 2025) Arterex, a leading global medical device developer and contract manufacturer, today announced the completion

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What is medical device manufacturing

What to Know About Medical Device Manufacturing?

What To Know About Medical Device Manufacturing? Written by Arterex Medical Published on November 29, 2024 Read time 7 minute read What Is Medical Device Manufacturing? Medical device manufacturing is the process of producing equipment, instruments, and tools used in healthcare for the diagnosis, prevention, monitoring, treatment, or alleviation of diseases and injuries. This industry

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