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Top 3 Requirements for Software as Medical Device (SaMD)

A deeper dive into crucial policies for Software for Medical Device (SaMD) Organizations
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Crucial Do’s and Don’ts of SaMD Development

Explore the unique challenges and considerations of SaMD development.
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Guide to HIPAA Compliance: Achieving & Maintaining Data Security

Step by step guide for obtaining HIPAA Compliance for your Healthcare or Life Science organization.
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What Atlassian's Elimination of Jira Server Means For Your Business

How the transition from Jira Server to Jira Cloud will impact Healthcare and Life Science Companies
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Case Study: Safe Health

How Sierra Labs helped Safe Health win enterprise customers with HITRUST and SOC2 Compliance.
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The Importance of SOC 2 Certification for Healthcare

How SOC 2 Certification provides security and value for Medical Device Companies.
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Guidance on HIPAA Compliance for Medical Devices

Defining HIPAA Compliance as it pertains to your Medical Device Company.
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Using Agile in SaMD Development Under IEC 62304

Uncovering how Agile practices fulfill Software as a Medical Device (SaMD) Development
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A Regulatory Approach Manual for Device Software Functions

Understanding the policies for your Medical Device Software Functions
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A Quick & Easy Guide to FDA Pre-Submissions

A simple guide to conquering your Pre-Submission Meeting with FDA, plus some free tools!
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