Medical Technology

Panacis has a deep understanding of the regulations that constrain the design and manufacture of medical devices.

Modern medical devices employ convergent technologies, bringing life sciences together with a range of technical disciplines to create compelling solutions for unmet medical needs. Such products may include the use of advanced materials, the latest microelectronics modules, vision systems, or time-critical processing and control systems.

Increasingly, medical devices are being created or adapted for mobile use, requiring a strong understanding of packaging, of component selection, and of the power budgets that affect device utility. Panacis battery systems are exceptionally light and compact. This facilitates patient recovery by encouraging activity and mobility. In one case we were able to replace a 3300 gram battery with a 340 gram battery that had similar capacity, lower maintenance and higher overall reliability.

Panacis has developed and manufactured a number of successful medical devices and diagnostic instruments for our customers, and has helped to conceive and validate many more. Occasionally, we will collaborate with research institutions to develop product or technology concepts, in order to advance applied research.

Panacis’ experience with medical technology comes from having designed, produced, and launched its own medical devices, which continue to be manufactured in its facility and sold around the world.

Examples

  • Designed and manufactured a low-cost, high-speed DNA analysis instrument.
  • Designed and manufactured batteries and charger for an implanted heart assist device.
  • Designed and manufactured a therapeutic device for children with musculoskeletal disorders.
  • Designed and licensed a diagnostic device for detecting swallowing disorders in stroke patients.
  • Designed a high-power battery for a portable ultrasound system.

Quality

We at Panacis have a direct understanding of the medical technology industry for having conceived, developed, and manufactured our own medical devices. From this experience comes a deep understanding that product quality comes not just from the integrity of design and controls in manufacturing, but also from the overall product development process. Occasionally, we are also called on to conduct third-party design reviews as part of risk mitigation strategies.

Our ISO 13485 quality system experience allowes Panacis to undertake the design and manufacture of medical device products for global regulatory approval. We have also sucessfully completed third-party design reviews as part of ISO 14971 risk mitigation strategies.

Regulatory

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:

  • CSA/UL/MET
  • FDA
  • CE marks
  • FCC
  • UN/DOT

Panacis manufacturing facilities are routinely audited for compliance with quality and regulatory standards.