Safe, reliable power that’s fit for portable healthcare
In the quest to quell rising health care costs, portable medical devices are being prescribed with increasing frequency. Globally, the medical device market is expected to reach $350 billion by 2016 as more patients are served remotely with injection and infusion pumps, medical monitors, portable X-ray units, diagnostic equipment and an array of other home health devices.
While portability and miniaturization make medical electronics more practical, the true measure of effectiveness โ and regulatory approval โ is contingent on connectivity, safety, data security, quality and reliability. Performance failures may mean the loss of a patient or the deterioration of their health.
With so much at stake, many of the world’s leading medical OEMs and contract manufacturers partner with GBP. We have a nearly 20-year track record of providing safe, high-reliability battery packs for healthcare and other mission-critical businesses. Through our independent and accredited test lab, we can design, test, and certify each battery pack to the most stringent of medical industry standards, ensuring:
- ISO 13485 and UL 60601 compliance;
- Design History Files (DHF) and Device History Records (DHR) for FDA approval;
- Design Failure Mode and Effect Analysis (DFMEA) for design process risk mitigation;
- Process Failure Mode and Effect Analysis (PFMEA) for manufacturing process risk mitigation;
- Certificate of Compliance (CoC) and quality assurance checklists; and
- Continuous improvement, lean manufacturing and Just in Time product delivery.
Our commitment to reliable, high quality battery packs has made us a qualified supplier for medical devices.