IEC 62304 software lifecycle documentation, SaMD regulatory support, software validation and medical device cybersecurity.
Medical device software needs documented processes that show how requirements, development, testing, changes and security are managed. DnA supports software and SaMD teams in building regulatory evidence that connects lifecycle activities with validation and applicable cybersecurity requirements.
Establishing or reviewing IEC 62304 software lifecycle documentation
Preparing regulatory documentation for Software as a Medical Device (SaMD)
Validating medical device software against intended use and defined requirements
Addressing medical device cybersecurity, including IEC 81001-5-1 where applicable
Structure software requirements, architecture, verification, configuration, maintenance and change records to support traceability throughout the software lifecycle.
Develop regulatory and validation evidence around intended use, software requirements, test results, defect handling and controlled software release.
Address cybersecurity risks, vulnerabilities and security controls with supporting documentation, including IEC 81001-5-1 considerations where applicable.
Software changes can affect requirements, validation evidence, identified risks and cybersecurity controls. DnA Regulatory Solutions helps teams maintain these connections so software documentation remains traceable and relevant as devices are developed, updated and maintained.
Maintain traceability between software requirements, testing and release evidence
Coordinate software validation with risk management and change control activities
Review vulnerabilities, software changes and cybersecurity evidence throughout the lifecycle
Built for Software That Continues to Change:
Medical device software does not remain static after release. DnA helps teams maintain lifecycle documentation, validation evidence and applicable cybersecurity controls as software versions, risks and regulatory requirements evolve.
DnA supports IEC 62304 software lifecycle documentation covering areas such as software requirements, architecture, verification, configuration, maintenance, change control and related regulatory records.
Yes. DnA supports Software as a Medical Device with regulatory documentation and software validation activities aligned with the device, intended use and applicable requirements.
Yes. Support includes cybersecurity documentation, vulnerability and security-control considerations, with reference to IEC 81001-5-1 where applicable.
Build connected regulatory evidence across IEC 62304 lifecycle documentation, SaMD, software validation and applicable medical device cybersecurity requirements.