Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

EUA 101: What is Emergency Use Authorization and How can my Device get Authorized?

By Jon Speer on May 17, 2020

On Saturday, March 28, health care workers in Los Angeles County discovered that the federal governm...

How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices

By Nick Tippmann on May 13, 2020

What is artificial intelligence (AI) and machine learning (ML) and how do the two differ in the medi...

[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem

By Nick Tippmann on April 22, 2020

What impact will the EU MDR changes have on the medical device ecosystem?

How to Approach Verification and Validation for Cloud Software

By Nick Tippmann on April 15, 2020

Why is verification and validation (V&V) confusing and challenging for many medical device profe...

[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD)

By Nick Tippmann on March 26, 2020

In this modern digital world, did you know that most medical devices are not connected to the Intern...

How to Leverage IEC 62304 to improve SaMD Development Processes

By Nick Tippmann on March 18, 2020

How can the IEC 62304 standard serve as a framework for your Software as a Medical Device (SaMD) dev...

Implementing Changes to SaMD under New EU MDR

By Nick Tippmann on September 4, 2019

Classification, qualification, and other changes to Software as a Medical Device (SaMD) under the ne...

What are the Regulatory Expectations for Software as a Medical Device (SaMD)?

By Jon Speer on September 23, 2018

In today’s highly connected world, medical devices often include state-of-the-art software, or, the ...

What Are the Regulatory Expectations for Software as a Medical Device (SaMD)?

By Nick Tippmann on August 22, 2018

These days, medical devices often include software or are standalone software. So, software as a med...

What is Software as a Medical Device (SaMD)?

By Jon Speer on November 13, 2017

Medical devices are a big business covering a wide range of modalities and applications. To ensure t...

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