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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Medical Device Single Audit Program (MDSAP) Explained

A simple breakdown of MDSAP, how it can benefit your company, and detailed instructions on how to get started.
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ISO 13485 - Regulatory Requirements on Medical Devices

How embracing regulations can give you a leg up on your competition.
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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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A Simple Guide to SaMD

Breaking down the basics of Software as a Medical Device (SaMD): risk categorizations and examples.
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Embrace Agile in SaMD to stay competitive!

Learn how to implement Agile into your SaMD development and also stay compliant.
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