Testing Services for the Medical Device Market


Your product capability and reliability are literally the lifeblood of your company. Your products must perform exactly as the customer expects, every time. DTB can help. We can provide support from conceptualization through prototype and into production.



TESTS METHODS



  • Electrostatic discharge (ESD)

  • Radiated RF electromagnetic energy

  • Conducted RF electromagnetic energy

  • Magnetic fields

  • Electrical fast transients and bursts

  • Surges

  • Voltage dips

  • Short interruptions

  • Voltage variations on power supply input lines

  • Vibration

  • Temperature

  • Bump

  • Drop test



ENGINEERING and TESTING


Our engineering services group will assist you with “designing in” reliability and robustness by tailoring a unique test protocol to evaluate potential failure modes. For electronic equipment we can also validate EMI/EMC issues at the prototype stage before large investments are made on your part. We can also assist with complete design verification testing after prior R&D gates have been satisfied.



PORTABLE EQUIPMENT


Do you have a portable equipment development program? We specialize in consulting on “Ruggedized” designs. We can pass your product through a virtual gauntlet of real world environmental exposure to expose any potential problems before you go to market. There are no limitations to the type of medical device that we can test, mechanical or electro-mechanical devices are not a problem for us.



LARGE FIXED EQUIPMENT/SYSTEMS


DTB also services products that are large scale and primarily designed into a fixed location. Your systems still need to be evaluated for their intended environment . We can help with two different approaches.

First, our massive facility is designed to accommodate large scale projects, we own serveral oversized environmental chambers, and we can also consult on validation of sub-system level testing.

Second, let us come to you. We routinely visit customer locations with portable test equipment for EMI/EMC evaluations, instrumentation work, and even on-site special purpose environmental testing.



CLASS I MEDICAL DEVICE TESTING IAW



  • Standards

  • Class I Devices

  • EU/EMC 93/42/EEC

  • FDA’s Pre-market guidance requirements (21 CFR)

  • IEC 60601-1-2 – 2001Safety/MI/EMC

  • R&TTE - Directive for Intentional Radiators

  • 47 CFR. Part 15

  • IEC 801

  • FCC, Part 18

  • ANSI C63.18


Click here for a PDF document entitled "Guidance on Wireless Medical Devices".


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