AI, Software & Digital Health Devices

We are here for you every step of the way. With our support and advice, you can be confident of meeting your regulatory requirements right from the start.

BioReg Services is a medical device consultancy specializing in AI, Software & Digital Health.

Artificial intelligence can be defined as “[a] machine’s ability to make decisions and perform tasks that simulate human intelligence and behavior.
Artificial intelligence in medical devices is employed to fulfill human capabilities in a variety of roles with deep learning techniques using neural networks, which include, but are not limited to:

  • Prediction and identification of diseases
  • Data classification and analysis for disease outbreak
  • Optimization of medical therapy
  • Diagnostic support application

BioReg possesses leading competence in assessing AI, software in medical devices & digital health medical devices, and applications in general. With a sound understanding of the regulatory safety and performance standards, we assess if manufacturers meet the state-of-the-art requirements of AI-driven medical devices to minimize regulatory compliance issues during certification and surveillance audits and technical documentation.

In one of our previous posts, we discussed the regulation of

Mobile Medical Apps & General Wellness Products

BioReg services can write the following cybersecurity documents based on Product and QMS information provided by the Company:

  • Cybersecurity Risk Management Plan
  • Cybersecurity Risk Management Report, which will include:
    o Threat modeling
    o Cybersecurity risk assessment
    o Software Bill of Materials (SBOM)
    o Vulnerability assessment and Software support
    o Security assessment of unresolved anomalies
    o Cybersecurity Traceability
  • Tracking Measures and Metrics
  • Security Architecture Views
  • Cybersecurity Design controls
  • Cybersecurity test plan
  • Cybersecurity labeling

Our team can perform the required Cybersecurity testing, such as vulnerability testing (scan) and penetration testing (Pentest).


In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.

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