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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How to Meet Regulatory Expectations for SaMD
Leveraging these expectations to ensure the highest level of quality for your Software as a Medical Device (SaMD)
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Case Study: Digiteyez Technologies
Digiteyez Technologies uses Sierra QMS to streamline compliance processes and tackle FDA regulations for their medical device, Clear.
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Case Study: Transparency Life Sciences
How Sierra Labs and TLS Partnered to Streamline Their Quality Process
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Pro Tips Surrounding Design Controls for Medical Devices
Breaking Down Design Control Requirements for Medical Device Development Teams
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The Ultimate Quality Management System for Life Sciences
Must-Have Features & Functionality for Your Quality Management System (QMS)
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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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What is FDA's 21 CFR Part 820?
Unpacking the FDA guidelines and regulations under 21 CFR Part 820.
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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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