Medical Devices

Medical Electronics products have enabled trained technicians, physicians, and biotechnologists to not only improve life expectancies, but also provide important data for groundbreaking research and analysis. Manufacturers are tasked with developing the most efficient product while facing a growing number of transitions including; a push towards more sophisticated technology; the production of smaller, more compact products; changes in design ergonomics; a rise in combination products; and increased regulatory rules.

CIMTEK ensures that quality medical devices are produced quickly and cost-effectively, while managing necessary information tracking through medical device testing solutions.

Examples of medical devices CIMTEK has developed testing solutions for include:

• Defibrillators
• Continuous Positive Airway Pressure (CPAP) ventilation
• Pacemakers
• Magnetic resonance 
• Implanted devices
• Patient monitoring equipment

CASE STUDY:

A customer in the medical device market needed to ensure that their CM (Contract Manufacturer) would produce product with the required quality to ensure the customers GMP (Good Manufacturing Process) would be maintained. The customer had a concern that the cost of Regulatory maintenance would increase substantially if quality could not be maintained, as well as the potential Brand value issues that could be affected.

CIMTEK worked with the customer and the contract manufacturer to define the test process, the outcomes, and the project timelines. CIMTEK utilized its QLM software product to deliver the information to the customer all the way through the production process at the CM. The net result was an increase in quality, efficiency and reduction in costs. The gains for the contract manufacturer included lower cost of test systems, greater throughput and less bottlenecks.