Blood Bank Device Expertise
Aptiv Solutions works with medical device manufacturers to meet clinical, compliance and FDA CDRH, CBER and international regulatory requirements for blood banking / blood collection related products and accessories. Our experience includes regulatory and clinical trial services for:
- Instruments and software used for control of blood samples in blood bank environments – software documentation review, 510(k) premarket notification preparation
- Blood cell separators / platelet and plasma procurement for healing wounds – clinical study monitoring and data management
- Blood filtration devices – FDA regulatory guidance and consulting, clinical trial database development, clinical study reports, clinical monitoring
- Blood component processing system – FDA regulatory response / communication support
- Blood typing tests and systems – FDA pre-IDE guidance and support, FDA submissions
Blood Bank Device Case Study
A manufacturer of blood bank instrumentation developed an interface for facilitate communication between instrumentation used for testing blood bank samples and the blood bank laboratory information system (LIS). The manufacturer turned to Aptiv Solutions for assistance with the development of appropriate medical device testing and assembly of the proper software documentation to support the company’s 510(k) premarket notification. With our support the client was able to adequately describe the integration of the software with the off-the-shelf software packages that are integrated into the device and develop an appropriate software validation testing program to demonstrate the integrity of data and patient information between the connected instrument and the LIS.
Blood Bank Device Case Study #2
An established manufacturer of medical devices developed a modification to its existing transfusion management system. The modified system was intended to manage information pertaining to blood samples in a transfusion center, store and retrieve patient and sample information, and issue required reports. With our assistance the company was able to clearly define the scope of the modifications made to the system and determine which of these changes would require the submission of a new 510(k) premarket notification. Our team was also able to help the company develop a successful software validation program and select the appropriate software documents to include in its 510(k) submission.
Contact us today to learn more about our blood bank device expertise.
