In the design and development of safe, effective medical devices, reducing risk and ensuring reliability must be top priority. Not only are these aspects of product quality mandated by agencies and organizations like the FDA and the CDRH, they are the moral and ethical imperative of all medical device manufacturers.
Methods for risk analysis and risk control often vary by company, device type, and application, but all methods must address any applicable quality standards, for example:
Table 1: Several key international standards for medical device reliability and medical device software reliability
The ramifications of not strictly adhering to these standards can include serious legal and ethical liabilities. Medical device manufacturers must have the tools in place to accurately and efficiently manage the risks associated with their products.
Read this whitepaper to learn about various methods for managing product reliability and risk and the PTC software solution that can support them.
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