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Integration der Mechanik-, Software- und Elektroniksystementwicklung für den Einsatz in Fahrzeugsystemen
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Construction, mining, and agricultural heavy equipment manufacturers striving for superior performance
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Siemens PLM Software, a leader in media and telecommunications software, delivers digital solutions for cutting-edge technology supporting complex products in a rapidly changing market.
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Explore IndustrySiemens Digital Industries Software Siemens Embedded & Medical Safety
Siemens Digital Industries Software Siemens Embedded & Medical Safety
Designers of medical devices have many more issues to consider than developers of other types of safety equipment. Medical devices are complex. In addition to various types of users (possibly including the patient), medical devices have complex communication requirements, including safeguarding confidential patient data. Medical devices must achieve their therapeutic goals while minimizing risks to patients and those who interact with the devices.
More in-depth safety considerations are required since these devices monitor or treat the health of patients; therefore, any issues can directly impact a person’s safety.
For example, device graphics that care providers need are complex, so governments have built regulatory infrastructures (such as the U.S. Food and Drug Administration) to review and approve devices before they are marketed and used for their intended purposes.
Designers of medical devices have many more issues to consider than developers of other types of safety equipment. Medical devices are complex. In addition to various types of users (possibly including the patient), medical devices have complex communication requirements, including safeguarding confidential patient data. Medical devices must achieve their therapeutic goals while minimizing risks to patients and those who interact with the devices.
More in-depth safety considerations are required since these devices monitor or treat the health of patients; therefore, any issues can directly impact a person’s safety.
For example, device graphics that care providers need are complex, so governments have built regulatory infrastructures (such as the U.S. Food and Drug Administration) to review and approve devices before they are marketed and used for their intended purposes.
In the United States, any medical device requires Premarket Notification Submissions (and approvals) through the FDA’a 510(k) Submission Process.
As part of the 510(k) submission package and subsequent review, the FDA reviews the patient risks and medical benefits of the device before it may be allowed to be released to the public. This review is all-encompassing, including safety, security and functionality components of the type of medical device being reviewed.
The FDA puts a high level of scrutiny on any third-party software to be used in the device, both from safety and security standpoints.
As a trusted supplier to medical device manufacturers, Siemens Embedded has the products, services and expertise to support these goals and to assist the manufacturer through this exacting process.
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