Things You Need to Know About Medical Device Software Validation

Software Verification and Validation (Software V&V) is an integral part of software design that spans all the development stages as specified in IEC 62304 which addresses the Software Development Life Cycle (SDLC) of medical software and software embedded within medical devices. Software Verification is to test if the software was designed as per requirements and Software Validation is to test if the right product was built for the user. Medical device software validation generally occurs during or at the end of the development cycle. 

The difference between Software Validation & Software Verification can be answered by asking these mentioned questions:

  • ·         Verification: Are we building the product, right?
  • ·         Validation: Are we building the right product?

Software validation is a process of checking if the product will meet the customer’s actual needs, while verification involves procedures for making certain that the software is well-engineered, free of errors, and functional.

Following are the steps for Software Validation for Medical Devices

  • ·         Create a software validation plan
  • ·         Determine system requirements
  • ·         Create a validation protocol and test specifications
  • ·         Conduct and document tests
  • ·         Establish procedures and write your final report

IZiel has highly trained software engineers with multiple years of experience in software coding, software verification and software validation. The team consists of senior engineers who have worked in the design and development of highly sophisticated implantable devices at industry-leading companies, with direct expertise in software V&V.

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