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Software Developers in the Health Space
For software developers in the healthcare space, navigating regulatory requirements is crucial for ensuring product compliance and boosting sales. Simply Compliance is here to help you meet these standards, enhancing your product's credibility and marketability.
Our Compliance Services Include:
• FDA Compliance Assistance for Software as a Medical Device (SaMD) including design controls, risk management, and premarket submissions.
• Regulatory Updates and Guidance
• Compliance Training for Product Teams
• Interoperability Standards (HL7, FHIR) Compliance
• HIPAA Compliance Support
• Data Privacy and Security Policies
• Security Risk Assessments
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