New FDA Guidance Regarding Bench Testing

Five action items to address Artificial Intelligence/Machine Learning- based SaMD

Software as Medical Device (SaMD) Challenges and Opportunities for 2021 and Beyond Webinar

FDA Digital Health Center of Excellence Listening Sessions

Rook Quality System Announces the Launch of Its First Asia-Pacific Based Branch located in Taiwan

Enforcement Policy - Digital Health Devices For Treating Psychiatric Disorders During the COVID-19

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