What is ISO 13485:2016?
An easily digestible overview of ISO 13485 and how it applies to your medical device company.
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FDA Pre-Cert 101: Beginner's Guide + Latest Updates
A simple breakdown of the Software Pre-Certification Program and how it affects your company.
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Medical Device Software & SaMDs: A Crash Course
A quick and easy rundown of ISO and IEC standards.
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New Medical Device & Life Science Collaboration Platform
Sierra Policies Quick Start video out now!
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ISO 13485 vs. CFR Part 820
A comparative study on the key differences between FDA’s QSR and ISO’s QMS.
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ISO 14971 Risk Management in Under 5 Minutes
Defining medical device risk while taking a sneak peek into ISO 14971:2019.
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Shape the future of FDA Regulations for AI/ML.
The proposal for AI/ML based SaMD regulatory framework is out now and you can influence the FDA!
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3 Steps to a GxP Cloud!
Do you want to transition to the cloud but have concerns about staying compliant? Below is your 3 step success guide for a digital transformation to a GxP Compliant Cloud.
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