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  12 Design and Engineering benefits of co-locating medical device manufacturing

  Benefits reaped from working with design and development firms that co-locate medical device manufacturing.

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  Get the most out of working with a contract manufacturer

  Working with a contract manufacturer questions to help choose the right partner and get the most out of a contract manufacturing relationship.

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  Expedited Access Pathway: timely medical devices for patients with life-threatening conditions

  Expedited Access Pathway (EAP) is promising for timely approval and access to devices for life-threatening or irreversibly debilitating conditions.

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  FDA reports faster medical device approval

  Recent report on policies and initiatives claims the FDA device arm (CDRH) medical device approval process is much faster than five years ago.

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  Sketch to Launch commercialization process for medical devices

  Sketch to Launch commercialization process for medical devices guides translational services to the medical industry.

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  The secret to closing open CAPAs by 50%

  How a mock FDA inspection led us to learn the secret to closing open CAPAs by 50%. Vesna Janic shares the story and her tips.

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  When to implement your Quality Management System

  Advice, implications and examples for best time to implement a medical device Quality Management System in US, Canada and Europe.

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  Data de-identification for personal health information security

  Data de-identification should be the first option to consider when dealing with Personal Health Information (PHI) security.

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  Meeting with the FDA

  Meeting with the FDA can put almost everybody in the company in panic mode. Benefits of FDA meetings and what to expect.

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