Regulatory Framework Overview
Medical imaging equipment is subject to extensive regulations to ensure patient safety. Understanding these requirements is essential whether purchasing new or refurbished equipment.
FDA Regulations (United States)
- 510(k) Clearance: Most imaging devices require premarket notification
- Quality System Regulation (QSR): Manufacturers must follow 21 CFR Part 820
- Medical Device Reporting: Adverse events must be reported
- Refurbisher Requirements: Legitimate refurbishing activities are defined
CE Marking (European Union)
- Medical Device Regulation (MDR) 2017/745 compliance
- Conformity assessment procedures
- Technical documentation requirements
- Post-market surveillance obligations
Radiation Safety Regulations
- State radiation control programs in the US
- Shielding requirements for CT and fluoroscopy
- Dose monitoring and optimization protocols
- Staff training and certification requirements
MRI Safety Standards
- ACR guidance for safe MRI practices
- Zone classification requirements
- Implant compatibility screening protocols
- Staff training requirements
Documentation Requirements
- Maintain equipment records for inspection
- Quality control test documentation
- Service and maintenance records
- Staff training records
Sunrays Image Technology ensures all refurbished equipment meets applicable regulatory requirements and provides necessary documentation for your compliance needs.
