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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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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