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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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What are CAPAs?

Learn the purpose of Corrective and Preventive Actions (CAPAs) for Medical Device Development.
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How to Create Successful SOPs for your Medical Device

Explore the key considerations for Standard Operating Procedures (SOPs) for Medical Device Companies
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What are Standard Operating Procedures (SOPs)?

Defining SOP’s as they pertain to your Medical Device.
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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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What is FDA's 21 CFR Part 820?

Unpacking the FDA guidelines and regulations under 21 CFR Part 820.
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5 Best Practices for Pharmaceutical Labeling

How strategic labeling can improve regulatory compliance and operational efficiency
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Quick Guide to a Successful Clinical Development Program

Unpacking the 4 stages of a Clinical Development Program.
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