Validation requirements apply to all medical device software regardless of its class or whether it is a software component or itself a medical device. Software validation should confirm that software specifications meet user needs and intended uses, and requirements can be consistently fulfilled. A software validation plan and procedure are required to outline and govern validation activities to develop confidence the device meets all user requirements. Since small changes can impact the system, validation status must be re-established after any change through appropriate regression testing to ensure no adverse effects. While off-the-shelf software validation can be difficult, the device manufacturer is responsible for compliance with FDA validation requirements through vendor verification and auditing design methodologies.

1. Software Validation for Medical Devices
By: Nikita Angane, MS
Validation requirements apply to software used as components in medical devices, to software
that is itself a medical device, and to software used in the production of the device or in
implementation of the device manufacturer's quality system. Any medical device software
developed after June 1, 1997, regardless of its class, unless exempted in a classification
regulation is subject to design controls. Specific requirements for software validation are in
21CFR 820.30 (g).i
Software is usually part of a bigger hardware system, software validation typically includes
evidence that all software requirements have been met, and hence the same design control
requirements apply to the software components of the device. Because software has the
capability to learn, adapt and improve with time, that could fix defects proactively (surveys,
interviews) and reactively (complaints, post-market surveillance), etc. These changes may
introduce new risks to the software. Hence, software validation should be conducted for all
software development projects including the changes/revisions made to the existing medical
device software.i
FDA defines software validation to be “confirmation by examination and provision of objective
evidence that software specifications conform to user needs and intended uses, and that the
particular requirements implemented through software can be consistently fulfilled.” According
to the FDA, software validation is a matter of developing a ‘level of confidence’ that the device
meets all requirements and expectations of the user from the software.i
All software subject to verification and validation requires a software verification and validation
plan. This plan will outline what will be accomplished as part of the validation effort. A Software
verification and validation procedure is also required that will govern the validation activities
more specifically the sequence of actions that must be carried out to complete the validation
successfully.i
Validation of software changes:
Since a small change in the software may create a big impact on the system as a whole, the
validation status of the software needs to be re-established once a change is made. Appropriate
regression testing must be carried out to demonstrate that the vulnerable portions of the software
have not been adversely affected.i
Validation of off the shelf (OTS) software:

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Validation of OTS software systems can be difficult because of the many unknown parameters to
the sponsor. However, the device manufacturer or the specification developer has the sole
responsibility of complying with the FDA software validation requirements. Vendor verification
and validation documents may be used in place of, or to support, the necessary deliverables.
Again, the responsibility to have all the documents in compliance with FDA regulations lies with
the device manufacturer or the specification developer. The vendor’s design and development
methodologies should be audited as part of the supplier quality program of your organization to
avoid any regulatory issues in the future.i
Struggling with the quality requirements for your software? Give us a call at 248-987-4497 or
email us at info@emmainternational.com.
i FDA (Jan 2002) General Principles of Software Validation;Final Guidancefor Industry and FDA Staff retrieved on
05/10/2019 from https://www.fda.gov/media/73141/download