by Jeremy Moore | Jul 24, 2024 | Quality Management, Compliance and Regulatory Guidance
Introduction to Quality Assurance vs Quality Control in Medical DevicesUnderstanding Quality Assurance (QA) for Medical DevicesWhat is Quality Assurance for Medical Devices?The Role of Quality Assurance in Medical DevicesKey Activities in Quality...
by Jeremy Moore | Jul 19, 2024 | Software as a Medical Device, Compliance and Regulatory Guidance, Product Development
Unlocking Regulatory Success: 510(k) vs De Novo Pathways for SaMDUnderstanding the 510(k) PathwayDefinition and Background of the 510(k) Pathway:Requirements of the 510(k) Pathway:Process for the 510(k) Pathway:Advantages of the 510(k) Pathway:Limitations of the...
by Jeremy Moore | Jul 12, 2024 | Product Development, Compliance and Regulatory Guidance
Why Risk Management is a Game-Changer for Medical DevicesUnderstanding Risk ManagementWhat is Risk Management for Medical Devices?Why is Risk Management Crucial in the Medical Device Industry?Key Components of Risk Management for Medical DevicesRisk Identification:...
by Jeremy Moore | May 30, 2024 | Compliance and Regulatory Guidance, Cybersecurity
Safeguarding Patient Data: Why HIPAA Compliance for Medical Device Startups is CrucialUnderstanding HIPAAWhat is HIPAA?Core HIPAA Requirements for Medical Device CompaniesPrivacy RuleSecurity RuleBreach Notification RuleArchitecting HIPAA Compliance for Medical Device...
