5 Ways to Stay Compliant with 21 CFR Part 11

Learn how to stay compliant with FDA's Part 11 in the age of automation!
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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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Untangling HIPAA, HITRUST, and SOC 2

Explore the differences and benefits of the following regulatory frameworks for SaMD.
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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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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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Crucial Do’s and Don’ts of SaMD Development

Explore the unique challenges and considerations of SaMD development.
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A Simple Guide to 510(k) Applications for Medical Devices

Easy Guidance for Abbreviated, Special, and Traditional 510(k) Clearance Applications
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6 Preliminary Questions Around FDA’s RTA Policy for 510(k)

Outlining the Preliminary Qualifications and Evaluation of FDA’s Updated RTA Policy for 510(k) Submissions
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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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8 Guidelines for your Medical Device Regulatory Strategy

Learn how your company can form a Regulatory Strategy in 8 easy steps.
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