If sample sizes need to be determined there are many statistical methods and assumptions related to this so decisions should be carefully considered. Two of the most commonly used sample tables are ISO 2859 for attibutes and ISO 3951 for variables.
IEC 62304 and other Emerging Standards Impacting Medical Device Software
Being Agile & Yet Compliant
ISO 14971 SaMD Risk Management
Software Risk Management
Medical Device Cybersecurity
Software Verification
IEC 62366 Usability Process and Documentation
Or just email training@softwarecpr.com for more info.