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Software as a Medical Device (SaMD) Compliance Challenges

Digital health is a varied collection of health technologies, including mobile apps, wearable devices, and artificial intelligence. Digital health devices allow healthcare services to be more accessible and cost-effective for the user. Software as a Medical Device (SaMD) is a type of digital health technology with software that provides treatment, aids clinicians in making decisions, and can provide early diagnosis of life-threatening diseases. 

Non-traditional medical device manufacturers like software developers are in unfamiliar medical device regulatory territory. On the opposite spectrum, regulators are faced with the challenges of regulating software that can have frequent updates, potentially changing the safety or effectiveness of the software. SaMD comes with various compliance challenges for the regulation of medical devices. 

Regulatory Challenges of SaMD

  • The ability to download software poses risks as the traditional physical boundaries of containment are no longer restraints, leaving a cyber security challenge to protect sensitive company data, including intellectual property, financial data, and personal patient information. Medical Device regulations categorize medical devices from lowest to highest risk. With advancements in digital health technology, some SaMD do not fit precisely into the categorization system created with traditional medical devices in mind. 
  • Artificial Intelligence allows for the enhancement of SaMD applications in image-based healthcare by continuously learning from the software's data. A regulator needs to know that there are no unintended consequences for the software’s intended purpose when the software delivers the output. Artificial Intelligence and Machine Learning compliance standards must be known and addressed holistically. 
  • Companies in the Life Sciences must meet compliance standards set by the EU, US, and other international regulatory requirements for medical device software. As updates are released, companies using SaMD must continuously adhere to compliance standards set for digital health software. 
  • Agile software development and maintenance processes in the medical device regulatory environment can further affect processes, productivity, and meeting regulatory requirements set by governing agencies. 
  • The regulation of networked medical devices and mobile medical applications is also affected by compliance requirements. Network security, application security, Internet of Things security, and Data security are some elements of cyber security that help ensure coordinated compliance throughout entire information systems.

Arbour Group can assist your Life Sciences company with your Software as a Medical Device (SaMD) challenges. We believe in a holistic methodology to address compliance, delivering extensive regulatory expertise and proven processes to help you achieve your compliance goals. Contact us today to find out more.