DTB Markets: Medical Equipment & Devices
Contact DTB to discuss the advantages we can provide for your medical device enterprise.
Considering the development of medical documentation?
Medical Equipment Manufacturers – DTB’s Technical Services Division provides the capabilities to author information systems to support new equipment as well as the ability to update existing documentation to evolving standards and client expectations.
Medical equipment repair personnel or biomedical equipment technicians, work on medical equipment such as defibrillators, heart monitors, medical imaging equipment (x rays, CAT scanners, and ultrasound equipment), voice-controlled operating tables and a multitude of critical equipment.
Of course, all equipment in health care is held to the highest standards of documentation. Equipment information systems must be professionally designed and deployed, providing operating and maintenance procedures on-demand. To critical buyers, these systems are often a primary consideration in the initial selection and purchase of the equipment. DTB can provide the comprehensive suite of services to satisfy a demanding and evolving marketplace.
Medical Device Testing Services
Your product capability and reliability are literally the lifeblood of your company. Your products must perform exactly as the customer expects, every time. DTB’s medical device testing services can help. We can provide support from conceptualization through prototype and into production.
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.
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.
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 several 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 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