• 

  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.

• 

  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.

• 

  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.

• 

  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.

• 

  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.

• 

  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.

• 

  Drawing Ponies and IEC 62366

  Using a design approach to investigate the user’s needs provides a head start on ISO 60601 Ed. 3 and IEC 62366 medical devices

• 

  5 Tips for FDA 510(k) Medical Device Regulatory Clearance

  FDA 510(k) medical device submission tips and advice: being adequately prepared is essential for a smooth submission.

• 

  6 Areas to Watch in FDA Wireless Guideline for Medical Device Development

  FDA Wireless Guideline is a guidance document for RF wireless technology in medical devices recommending a risk-based approach.

There are no posts to show