Goal
The project goal was to secure CE Marking for a Molecular Breast, Imaging medical device according to the European Medical Device Directive.
Background
A US medical device company developed a molecular breast imaging therapy system used as an adjunct to standard mammography that measure and image the distribution of radionuclides to aid in the evaluation of lesions in the breast tissue. The company identified a need to expand into the EU market.
Objectives
- Assess status of quality management system
- Assess status compliance to international standards
- Access all product labeling
- Determine additional applicable Directive
- Gain CE Marking
Regulatory Need
CE Marking for MBI System
Activities
- Review and input to 30 SOP and WI to meet EN ISO 13485 requirements
- Identify gaps and work with the company and test laboratory to conduct product safety and electrical safety testing to standards
- Major update to ISO 14971 risk management compliance
- Update all product labeling to international standards
- Comply with additional directives such as RoHS 2
- Create Technical File
- Select EU Authorized Representative and Notified Body
Outcome
- Liaise with Authorized Representative and Notified Body during creation and review of Technical File
- Gain approval from Notified Body and affix CE Marking
About MAE Group
MAE Group is a business service provider specializing in domestic and international Regulatory Affairs, Clinical Affairs, Quality Systems, Cybersecurity and Networked Security services to healthcare companies to commercialize medical and in vitro diagnostic devices in target markets.
