Standards vs. Regulations - What governs your medical device?

Posted by Sierra Labs on May 22, 2019 10:02:21 AM

A comparative study on the key differences between FDA’s QSR and ISO’s QMS.

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Topics: FDA, QMS, Medical Device, Compliance, New Draft, ISO, Regulations, Conformity

ISO 14971 Risk Management in Under 5 Minutes

Posted by Sierra Labs on May 14, 2019 9:51:50 AM

Defining medical device risk while taking a sneak peek into ISO 14971:2019.

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Topics: FDA, Medical Device, risk, Compliance, ISO

Shape the future of FDA Regulations for AI/ML.

Posted by Sierra Labs on May 3, 2019 10:54:28 AM

The proposal for AI/ML based SaMD regulatory framework is out now and you can influence the FDA! 


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Topics: FDA, Compliance, GxP, New Draft, Sierra Policies, ISO, ML, AI, Regulations

3 Steps to a GxP Cloud!

Posted by Sierra Labs on Apr 17, 2019 3:41:21 PM

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. In this guide, we will walk you through the different stages to a continuous validated cloud.

Let's get started!

 

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Topics: FDA, Cloud, Compliance, Validated Cloud, Annex 11, AWS, GxP Cloud

A Simple Guide to SaMD

Posted by Sundar Selvatharasu on Apr 2, 2019 4:32:42 PM

Breaking down the basics of Software as a Medical Device (SaMD): risk categorizations and examples.

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Topics: Agile, FDA, QMS, SaMD, Medical Device, risk

Embrace Agile in SaMD to stay competitive!

Posted by Sundar Selvatharasu on Mar 27, 2019 11:19:32 AM

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

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Topics: Agile, FDA, QMS, SaMD, Medical Device

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