Software Development For Medical Devices

Software is fast becoming the differentiator for manufacturers of medical devices. The rewards of software innovation are balanced by the risks and challenges of regulation, stringent quality requirements, market pressures, and significant complexity. Balancing these competing interests requires tailored application lifecycle management tools that address the unique needs of medical devices companies.

Software can serve as a source of innovation and a key differentiator for medical devices, especially given the adaptability of software and the speed at which software changes can be prototyped and implemented. Software is also becoming more voluminous and complex, which creates significant risk.

To further complicate matters, software components used in medical devices fall under regulatory scrutiny. Two prominent regulatory bodies include the FDA for medical device products marketed in the U.S., and the European Medical Device Directive for medical device products marketed in the European Union.

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For more information, please visit http://www.ptc.com/application-lifecycle-management/integrity