Best Practices For a SaMD MDR Application
Software as a medical device (SaMD) is a rapidly evolving field, posing opportunities and challenges for device organizations and regulators. We would like to dedicate this…
Peace of Mind At Your Fingertips: Digital Health Funding Explodes
To say that the Covid-19 pandemic has changed our lives is a major understatement. Since the outbreak, we’ve all experienced fear, anxiety and some form of…
New FDA Guidance Regarding Bench Testing
The FDA has recently posted new guidance regarding bench testing. FDA suggests including both test report summaries and complete test reports, when appropriate. Complete test reports…
Five action items to address Artificial Intelligence/Machine Learning- based SaMD
The FDA recently released an Action Plan to address Artificial Intelligence/Machine Learning (AI/ML)-based Software as a Medical Device (SaMD). The action plan is based on efforts…
FDA Digital Health Center of Excellence Listening Sessions
The two sessions were moderated by Bakul Patel | Director for the Digital Health Center of Excellence (DHCoE) On September 22, 2020, the FDA established the…
Software as Medical Device (SaMD) Challenges and Opportunities for 2021 and Beyond Webinar
This webinar was hosted by Andrew Wu, Branch Manager | Software Consultant at Rook Quality Systems. On December 9th, 2020, an online webinar regarding the SaMD…
Software Development Process for Healthcare Applications
Summary of Key Points Software development process require a variety of process planning activities that would address how you design, implement, and maintain software throughout its…
Understanding the Medical Device Single Audit Program and How to Prepare for it
This webinar was hosted by Kyle Rose, the President of Rook Quality Systems. You will find this webinar helpful for preparing the registration process with MDSAP…
Tips, Tricks, and Best Practices for Complying with ISO13485:2016
When it comes to 13485-2016, are you scrambling to meet requirements? Are you trying to figure out the how, what, or when regarding its timeline? Or,…
How to Conquer Supplier Management for Medical Device Companies
This webinar was hosted by Kyle Rose, the President of Rook Quality Systems. You will find this webinar helpful for understanding purchasing and supplier control process…