Blood Bank Device Expertise
MDCI works with blood bank device manufacturers to meet clinical, compliance and FDA CDRH, CBER and international regulatory requirements to bring the product to market, including:
- 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 typing systems
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 MDCI 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 MDCI’s 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 MDCI’s 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. MDCI 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.
Contact Us
Reach our Massachusetts office at 1-508-643-0434, Monday through Friday, 9:00 a.m. to 5:00 p.m. Eastern. Or fill out our contact form and a consultant will contact you directly.
Client Testimonial
The expertise and knowledge that MDCI shared truly helps us accomplish our mission of helping U.S. companies increase their export sales.
- International Trade Specialist at US Department of Commerce