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Documentation impacted by EU MDR

July 24, 2019

Medical Device Regulation - Getting Started Soon

August 1, 2018

[Podcast] Implementing Changes to SaMD under new EU MDR

September 6, 2019

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Andrew Wu

6 days ago
1 min

Key Considerations for SaMD Companies Developing and Commercializing Software as Medical Devices

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Andrew Wu

Mar 23
3 min

Enforcement Policy from the FDA to combat COVID-19

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Kyle Rose

Mar 18
2 min

Medical Device QA - Work From Home Tips

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Andrew Wu

Sep 6, 2019
1 min

[Podcast] Implementing Changes to SaMD under new EU MDR

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Aditi Pillai

Jul 24, 2019
2 min

Documentation impacted by EU MDR

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Andrew Wu

Jul 18, 2019
4 min

How do startups leverage FDA's Pre-Cert Working Model - Part 2

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Andrew Wu

Jul 18, 2019
3 min

How do startups leverage FDA's Pre-Cert Working Model - Part 1

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Kyle Rose

Jun 5, 2019
1 min

The Essential Guide to Preparing Your QMS For EU MDR

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Andrew Wu

May 29, 2019
3 min

Classification and Qualification of SaMD under MDR

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Kyle Rose

May 3, 2019
1 min

[Webinar] Preparing your QMS for EU MDR

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Andrew Wu

Dec 13, 2018
1 min

[Podcast] What are the regulatory expectations for Software as a Medical Device (SaMD)?

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Kyle Rose

Dec 13, 2018
1 min

[Webinar] How to conquer Supplier Management for Medical Device companies

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Rook Quality Systems

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Featured Posts

Key Considerations for SaMD Companies Developing and Commercializing Software as Medical Devices

Enforcement Policy from the FDA to combat COVID-19

Medical Device QA - Work From Home Tips

[Podcast] Implementing Changes to SaMD under new EU MDR

Documentation impacted by EU MDR

How do startups leverage FDA's Pre-Cert Working Model - Part 2

How do startups leverage FDA's Pre-Cert Working Model - Part 1

The Essential Guide to Preparing Your QMS For EU MDR

Classification and Qualification of SaMD under MDR

[Webinar] Preparing your QMS for EU MDR

[Podcast] What are the regulatory expectations for Software as a Medical Device (SaMD)?

[Webinar] How to conquer Supplier Management for Medical Device companies

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