Throughout the software development lifecycle, collaboration between interdisciplinary teams, including software engineers, quality assurance professionals, regulatory experts, and clinicians, is essential to ensure that the software meets the necessary requirements and standards for medical devices. Additionally, adherence to rigorous quality and regulatory processes is critical to achieving regulatory approval and maintaining compliance with applicable regulations.
Our software team can support your organization in achieving compliance and enhancing productivity within your software development operation, including cybersecurity aspects. We provide state-of-the-art support tailored to meet your needs and the rigorous demands required for CE-marking and FDA-approval. Leveraging industry best practices can streamline the process and ensure timely market access while meeting regulatory requirements and ensuring patient safety.
Generally, medical device software development and maintenance involves:
- Requirements specification
- Risk management
- Design and development
- Verification and validation
- Deployment and integration
- Maintenance and updates
- Documentation and traceability
Cybersecurity in medical devices is critical given the increasing integration of software and connectivity in healthcare technology. Many regulatory agencies have therefore focused specifically on this area with outlined regulatory requirements on cybersecurity and data privacy.
Your Quality Management System for medical devices needs to include at least the following cybersecurity considerations:
- Threat identification
- Risk assessment
- Secure design and development
- Authentication and access control
- Data protection
- Updates and patch management
- Network security
- Incident response planning
