Medical Device Imaging and Software
Aptiv Solutions has supported more than 70 regulatory and clinical trial projects involving a range of imaging devices and related software, including:
- Capsule endoscopy device – statistical analysis plan, study coordination, monitoring, data management, reader management, statistical analysis, clinical report, 510(k) preparation and submission
- Digital mammography imaging and software devices – clinical study monitoring, PMA and 510(k) preparation and submission
- Digital film imaging device – 510(k) preparation and submission, Canadian license application
- Digital pathology system – regulatory strategy, clinical trial strategy, pre-IDE, QSR assistance, clinical trial study and data management
- Software-based digital image management system for clinical and laboratory use – 510(k) preparation and submission
- Software and related system for cerebral cortex mapping – 510(k) preparation, submission, FDA negotiation and responses
- Medical imaging manipulation tool - regulatory strategy, pre-IDE, 510(k) preparation and submission
- Mobile fluoroscopic imaging device – 510(k) preparation and submission
- Medical image storage, communication and PACS devices and accessories – regulatory strategy, 510(k) preparation and submission
- Breast MRI scanner – Quality Systems guidance
- Dental CR scanner accessories – special 510(k) preparation and submission
Medical Device Software Case Study
U.S. based software company with no previous experience with the submission of submission of 510(k)s developed a software product for the management, viewing, and processing of DICOM-compliant images. The client was not familiar with FDA requirements for 510(k)s, software documentation, labeling, and development of DICOM conformance statements.
Aptiv Solutions performed a critical review of the company’s labeling and software documentation and provided a template and guidance for development of a DICOM conformance statement. Our team prepared the 510(k) and submitted the 510(k) to FDA along with the modified documentation. The device was cleared in less than five weeks with only one FDA request, which was to change the wording in the Indications for Use.
Contact us for more information about medical device software documentation.
