Mobile Apps & Software

Medical device software offers its own unique risks and challenges. For years, FDA has enforced strict requirements for software design and validation, above and beyond the requirements for medical device hardware. Now, medical device manufacturers are being tested by new international requirements, a dizzying array of mobile platforms, and the coming wave of cybersecurity threats. MCRA's experts have spent years validating software applications for medical device manufacturers and are well equipped to address the newest challenges. 

  • Create procedures for your device Software Development Life Cycle (SDLC) and quality software validation, in compliance with the latest requirements for the FDA QSR, ISO 134585:2016, and the new EU Medical Device Regulation
  • Ensure effective and efficient communications between software developers and top management as software is being written and tested
  • Plan and execute software validations that ensure compliance and withstand scrutiny during FDA inspections and Notified Body audits
  • Help your team incorporate cybersecurity and multi-platform considerations into every phase of software development, from user requirements to design and coding, all the way through to user site testing

 

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Dan Goldstein

Dan Goldstein

Manager, Quality Assurance