Standalone Medical Devices SCPR Services

SaMD. Standalone Medical Devices. Do you have SaMD or software systems that might be classified as medical devices, even if FDA has chosen not to regulate them? Do you know the features that might trigger medical device classification? Whether regulated or not, a well developed and sufficiently documented risk analysis and management plan is essential and the first step toward safe products. Contact SoftwareCPR to help you with strategic feature planning and software architecture decisions for your SaMD to confidently navigate the SaMD highway.

Upcoming Training

Agile Methods for Medical Device and Health IT Software

One day course that expands on the software risk management topics covered in our IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software course. Essentially the same topics are covered but in greater depth with more attention to hands-on analysis of examples.

Email for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.