Information Technology Compliance (IT)
MedTech Results audits and evaluates IT resources and policies for compliance to FDA medical device regulations and ISO standards. MTR validates IT infrastructure, products, and services to help organizations meet the requirements of:
- ISO 13485 Medical Devices
- ISO 14971 Risk Management
- ISO 62304 Software as Medical Device
- ISO 22301 Business Continuity Management Systems
- the federal HIPAA and privacy regulations
Artificial Intelligence/Machine Learning (AI/ML)
Medical devices that utilize AI/ML capabilities face distinct compliance issues. MedTech Results can help guide product development through these issues, ensuring that your Quality efforts conform to accepted practices in this emerging field.
Support of AI/ML compliance projects includes evaluation of the following issues, as needed:
- Intended Use
- Validation protocols & dataset evaluation
- Active vs Locked algorithms
- Risk analysis
- Human-factors design integration
- Performance monitoring requirements
- User information & communication, labeling
- Clinical Decision Support Software (CDS)
A review of these can indicate where compliance to FDA or ISO standards is required. Then MedTech Results can help implement and document any required Quality controls for AI/ML projects.
Do You Have Questions? Get In Touch!
Feel free to reach out to MedTech Results. We’re happy to discuss your needs or answer your questions almost anytime. We are normally available most weekdays in the Central Time Zone.