Digital transformation in the medical device industry
AI-powered and cloud-based smart digital health solutions, Software as a Medical Device (SaMD) and the Internet of Medical Things (IoMT) are driving innovation in the medical device industry.
As a result, innovative approaches for medical device design processes and post-market surveillance are necessary to achieve software engineering excellence while remaining compliant to regulations.
Services to support engineering excellence
Turn to UL Solutions engineers and consultants to help you address the above areas. Our experts have deep experience in the following topics:
- Medical software and systems development.
- Development of active medical devices, medical systems, and medical software in compliance to medical device regulations
- Development of medical software according to IEC 62304.
- Implementation of risk analysis according to ISO 14971.
- Implementation of usability engineering process according to IEC 62366
- Development of active medical devices according to IEC 60601 series.
- Development of in vitro diagnostic devices in compliance to IVDR.
- Support in setup of software development process to fulfill regulatory requirements in an efficient way.
- Development of active medical devices in an agile way according to TIR45.
- Development of medical software and systems in cloud environment.
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