last highlighted date: 2024-01-15
Highlights
- The healthcare industry’s rising dependence on technology is driving rapid growth within the medical device software market, which is expected to have a value of $8.2 billion by 2027.
- Embedded software must:
- Meet the essential requirements of the EU’s Medical Device Directive (MDR).
- Comply with the FDA’s Center for Devices and Radiological Health (CDRH) requirements.
- Meet cybersecurity requirements and eliminate medical cybersecurity vulnerabilities.
- Adhere to other regulatory compliance requirements for the specific type of device being created.