SaMD & AI

Unlock Success in SaMD and AI MedTech: Navigating Regulatory Challenges with CDMS

We specialize in developing and navigating the complex regulatory landscape for Software as a Medical Device (SaMD) and Artificial Intelligence (AI) MedTech Products. Software as a medical device (SaMD) and artificial intelligence (ai) MedTech – navigating the regulatory, quality and manufacturing challenges to unlock success.

CDMS will address the challenges faced by healthcare and MedTech businesses in the deployment of SaMD and AI technologies. We will focus on regulatory compliance, quality assurance, and manufacturing which will be an area to cater solutions, with a focus on overcoming core hurdles in these areas. The importance of involving specialists, contract manufacturing, and a review of current procedures will be highlighted. Key areas to concentrate on will be discussed, including CE certification, clinical evaluation, IT and cybersecurity, design and risk documentation, and FDA and EU clearances. The impact of remote auditing practices, the role of SMEs, and considerations for start-ups will also be covered. The ultimate goal is to provide actionable insights and guidance to ensure the successful deployment of SaMD and AI technologies in the healthcare and MedTech industries.

Critical questions requiring prompt attention:

  1. What steps can you take to ensure timely FDA and EU clearance?
  2. Is a substantial infrastructure required to bring your technology to market?
  3. Is your supplier prepared for unexpected audits?
  4. Is your contract manufacturer compliant with ISO 13485 or MDSAP standards?
  5. How ready are you for remote auditing processes?
  6. As a start-up, are you following best practices to ensure success?

Cybersecurity

Advanced technology, especially in SaMD and AI-driven MedTech products, has rapidly transformed healthcare, improving patient care through innovations like intelligent infusion pumps and AI in disease detection. However, the increased digitalization of medical devices brings cybersecurity challenges, including threats to patient safety and data privacy.

The U.S. FDA regulates medical devices, working with stakeholders to establish guidelines for cyber-secure products. Manufacturers are urged to proactively disclose vulnerabilities. This critical topic is discussed in a webinar, emphasizing the implications of medical device cybersecurity on patient safety, data privacy, and industry reputation. The FDA stresses the importance of staying informed and taking preventative measures, issuing “safety communications” for identified risks. Join us to understand the significance of cybersecurity for medical devices and learn best practices in this evolving landscape.

We demystify:

  1. What is a Cyber device?
  2. Medical device cybersecurity risk management
  3. Cybersecurity as part of Device Safety and Quality System Regulations
  4. Software Bill of Materials (SBOM) in the management of cybersecurity risks
  5. Current Trends and Regulatory updates
  6. How the FDA plays a vital role to regulate and reduce cybersecurity risk
  7. Manufacturer roles and responsibilities towards safer MedTech products