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  How to write a Medical Device Quality Manual (3 simple rules)

  Regulatory affairs expert explains how to write a best practice ISO 9000 Medical Device Quality Manual using 3 simple rules.

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  Electro-Medical Device Basic Safety Learning Lab Highlights

  Highlights from Day 1 of Learning Lab event at Boston BIOMEDevice on electro-medical device basic safety and achieving compliance with 60601.

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  5 Top Annual Plan Medical Device Design and Development Process Improvement Recommendations

  Medical Device Design and Development Process Improvement for Annual Plan: limit improvement efforts, measure them regularly, succeed.

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  Avoid Waste Preparing for Medical Device Regulatory Requirements

  The best way to avoid waste is to consider medical device regulatory requirements at a project outset.

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  RoHS 2 and Medical Devices: Compliance Overview

  RoHS 2 and Medical Devices impact design and manufacture. Failure to meet requirements could result in product recalls.

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  Reader Favorites: 10 Most Read StarFish Medical Device Blogs of 2013

  Reader Favorites: 10 Most Read StarFish Medical Device Blogs of 2013. From FDA Guidelines to EMS pre-screening to Medical Device Margins.

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  How to Handle Medical Device Risk Management and the change from ALARP to AFAP

  Medical Device Risk Management ALARP to AFAP, the Directive and Standard, implications and how to handle the situation.

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  Medical Device Design Documentation Risk Management, Verification & Validation (V&V), and Standards Tips

  Risk Management, Verification & Validation (V&V), and Standards tips for Medical Device Design Documentation. FDA 21 CFR 820 QSR regulations.

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  Planning, Input and Architecture Tips for Medical Device Design Documentation

  Three medical device design documentation tips for Planning, Input and Architecture when developing early stage medical devices.

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