Panacis improves the competitive advantage of your portable medical devices.
Increasingly, medical devices are being created or adapted for mobile use, requiring a strong understanding of packaging, component selection, and the power budgets that affect device utility. Panacis battery systems are exceptionally light and compact. This facilitates patient recovery by encouraging activity and mobility.
Panacis has developed and manufactured battery and charger systems for a number of successful medical devices and diagnostic instruments. We understand the regulatory requirements for medical devices from Class I to IV.
Product quality and medical regulatory compliance comes not just from the integrity of design and controls in manufacturing, but also from the overall product development process.
- We have been certified to ISO 13485 and are currently migrating our system to ISO 9001 in combination with FDA GMP (Good Manufacturing Practices).
- Our quality system experience allows Panacis to undertake the design and manufacture of medical device products for global regulatory approval.
- We have successfully completed third-party design reviews as part of ISO 14971 risk mitigation strategies.
Panacis provides support in obtaining the regulatory approvals necessary to launch a medical product in domestic and foreign markets, which may include registration, laboratory testing, or design review. Such regulatory approvals include:
- CE marks