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White Papers

2022 Guide: Software as a Medical Device (SaMD)

2022 Guide: Software as a Medical Device (SaMD)

What is software as a medical device? Software as a medical device, or SaMD is software that is intended for one or more medical purposes. This software performs those purposes without being part of a hardware medical device.  SaMD devices also need to meet the...

10 Success Factors of Future-proof Requirements Management

10 Success Factors of Future-proof Requirements Management

Codebeamer is the most Agile Application Management platform on the market. It’s scalable, integrated and supports collaboration - all while offering powerful features across the entire lifecycle. Staying ahead requires more than just cutting-edge tools—it demands a...

Leveraging PTC’s Integrity Platform for IEC 62304 Compliance

Leveraging PTC’s Integrity Platform for IEC 62304 Compliance

Executive Summary Our medical device customers report that up to 70% of new product innovation is being created in the software domain. This represents an increase in both volume and complexity.  How do you navigate that complexity with the rigorous compliance...