Company: Fortune 500 Medical Device Company
Industry: Medical Devices
Use Case: Class III Heart Pump Console
Services Used: Software, Diagnostics, Documentation, Verification
Results:
This large medical device company sells cardiac equipment. It acquired a smaller company with a proof-of-concept heart pump that serves as a lifesaving solution for people undergoing heart surgery.
This company engaged with Voler Systems because of its extensive experience in medical device design and development and strict federal regulatory requirements.
Voler Systems' engineers identified what was needed to take the pump from a proof-of-concept to reality. They implemented a development process to ready the heart pump for submission to the FDA. This systematic approach resulted in Voler Systems delivering the following solutions:
Upon review of the system, the FDA approved the software without any conditions or comments. This is significant, as there is a rare occurrence of no software modifications required by the FDA in a Class III medical device.
Voler System's approach helped ensure compliance with rigorous FDA regulatory requirements, provided confidence in the heart pump's safety and efficacy, and allowed the device to move to clinical trials more quickly.
Using a systematic approach, coupled with a passion for innovation and quality, Voler Systems can offer you the expertise needed to develop a safe and reliable medical device that meets FDA standards and clinical needs.
"Voler Systems' expertise and attention to detail were instrumental in developing a heart pump console that met regulatory standards, exceeded clinical needs, and ensured patient safety."
Contact us and let us help you achieve success as you make a positive impact on patient care.