Get SaMD consulting for software as a medical device regarding regulatory compliance, documentation, cybersecurity, quality management, and information security management.
Software, whether embedded software in a medical device (SiMD) or Software as a Medical Device (SaMD), has specific regulatory requirements. It is crucial to determine whether the software qualifies as a medical device and its classification under the relevant regulatory framework.
Software as a Medical Device (SaMD) can be either a medical device or an in-vitro diagnostic (IVD) medical device. However, applying regulations and standards such as ISO 13485 can be challenging, as they were not originally designed for SaMD compliance solutions, especially modern software development processes.
At MedQAIR, our SaMD consulting services provide expert guidance in aligning software development with medical device standards like ISO 13485 and ISO 14971. We also address key requirements, including software architecture, SOUP and OTS management, configuration control, cybersecurity (per IEC 81001-5-1), SaMD documentation, verification and validation, usability, and clinical evaluation. We have broad expertise in the European Union and the United States and have supported organisations in setting up and hosting pre-subs, 510(k) files, 513(g) requests, and Breakthrough Device Designation requests, and writing technical documentation for CE marking purposes.
Additionally, our SaMD consultants specialise in configuring electronic quality management and technical documentation systems, ensuring compliance and efficiency in software lifecycle management for software healthcare applications.
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