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 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

  • A low-cost, high-speed DNA analysis instrument,
  • A therapeutic device for children with musculoskeletal disorders, and
  • A diagnostic device for detecting swallowing disorders in stroke patients.

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.

With an accredited ISO 13485 quality system, Panacis is able to undertake the design and manufacture of medical device products for global regulatory approval. Occasionally, we are also called on to conduct 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

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