Outsourcing Software development for Medical Devices
  • CODE : HURD-0007
  • Duration : 60 Minutes
  • Level : Intermediate
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Don Hurd has over 40 years of experience in supporting the development of applications of or containing software in regulated industries, the last 20 in medical devices.

  • Established company QMS and led company to 13485 registration (12+ years); dual registration to 9001 (8+ years)
  • Successfully led numerous companies through standing up a new QMS, leading to ISO 13485 certification

Serving as ‘Quality Manager’ and ‘Management Representative’ for several companies.


Many companies do not want to invest in building a software team and outsource the software development efforts for their medical device.  Selecting the right development company can make or break your project. Even after selecting your partner, you still need to manage them. We’ll give a high-level overview of the software development process and what you need to know in order to ensure your software development partner is developing what you need and enabling your compliance with regulatory requirements. Participants will learn about what to look for when selecting a software development company. Participants will be provided some guidance on managing software development.

Areas Covered 

  • State of the industry
  • Software lifecycle overview
  • Integrated processes
  • Considerations for selecting a software development partner
  • Managing the software development effort

Who Should Attend

  • Management
  • Project Managers
  • Quality Engineers
  • Purchasing

Why Should You Attend

Software is increasingly used in and as medical devices. Software development isn’t something you can just jump into! Many companies are turning to outsourcing for software development, but you can’t just choose any software development team. Choosing the wrong partner may lead to patient harm,  recalls, inability to maintain the product, and sunk costs. Choosing the right software development partner and properly managing them is a must.

  • $199.00



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