Software helps ensure medical-device compliance

The Enterprise Risk, Compliance, and Quality Management Platform provides a centralized, enterprise–wide, fully Web-based solution for advanced quality planning, adverse event reporting, change control management, and complaint handling. The platform also tracks document control, engineering drawing control and collaboration, employee certification and training, and equipment maintenance and calibration. In addition, the solution handles internal and external audits, nonconformance management, process management, regulatory submissions, risk management, SOP enforcement, and supplier quality management.

Pilgrim Software Inc.
2807 W. Busch Blvd., Suite 200
Tampa, FL 33618
(813) 915-1663
www.info.hotims.com/36186-505

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Software helps ensure regulatory and customer compliance

Windchill Product Analytics, part of Windchill product lifecycle management (PLM) software, helps medical-device companies mitigate risk and ensure products are compliant with government regulations including RoHS, REACH, WEEE, FDA Title 21 CFR part 11, and EuP. The software provides regulators with detailed reports for numerous regulations and it also generates reports to help satisfy customer requirements for environmental data such as the Kaiser Permanente Sustainability Scorecard. Windchill Product Analytics even helps manufacturers comply with revised RoHS directives to be implemented in 2014 that include medical devices as well as monitoring and control instruments.

PTC
140 Kendrick St.
Needham, MA 02494
(781) 370-5000
www.info.hotims.com/36186-506

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FE software for simulating biomedical-device transmitters

The FCC recently ruled that the finite element method (FEM) is a valid technique to simulate a medical device that must communicate with other similar devices. HFSS analysis software can provide proof or validate that a biomedical-device transmitter design meets Federal Communications Commission (FCC) standards.

Certain medical implants and other equipment often contain transmitters that communicate with other devices — transferring physiological data to a doctor via wireless communication, for instance, which can be used to monitor, diagnose, or treat a patient’s condition. The new FCC ruling applies to transmitters that are placed inside, on, or in close proximity to the human body.

Device developers must ensure their equipment meets radio frequency (RF) emission safety standards. Additionally, manufacturers must comply with specific absorption rate (SAR) regulations, a measure of how the body absorbs energy when exposed to an RF electromagnetic field. HFSS software employs FEM simulation to verify both SAR and RF emissions.

Ansys Inc.
275 Technology Dr.
Canonsburg, PA 15317
(724) 746-3304
www.info.hotims.com/36186-507

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Software renders 3D models from medical-imaging formats

ImageVis3D is an open source volume renderer that supports all the common operating systems. ImageVis3D can read in a wide variety of file formats typical to the medical imaging field such as DICOMs, image stacks, Analyze 7.5, Kitware MHD files, BOV meshes, and NRRDs, in addition to a variety of formats from other domains. The program can be downloaded and used completely free of charge for any purpose. The software’s scalability lets it work on notebook computers as well as high-end graphics workstations. Users can interactively explore terabyte-size data sets.

The Center for Integrative Biomedical Computing
University of Utah
72 S. Central Campus Dr.
Salt Lake City, UT 84112
(801) 585-1867
www.info.hotims.com/36186-508