Empowering the SDLC with Tools to Bridge R&D and QA Teams
In the complex world of medical device development, the gap between Research and Development (R&D) and Quality Assurance (QA) teams can often lead to significant challenges…
Mastering Cybersecurity in Medical Devices: Key Strategies and Tools
Cybersecurity is critical for medical devices in today’s rapidly evolving regulatory landscape. With increasing cyber threats, robust cybersecurity practices are essential to prevent disruptions in patient…
Navigating the Intricacies of Medical Device Software Regulations
In an ever-evolving healthcare landscape, medical device software (SMD) remains at the forefront of technological advancements and regulatory scrutiny. During a recent webinar hosted by RookQS,…
Leveraging AI for Enhanced Healthcare Delivery
In the evolving landscape of healthcare, artificial intelligence (AI) stands out as a revolutionary force capable of addressing some of the industry’s most pressing challenges. From…
Preparing For Your First FDA or ISO Audit
Our recent blogs on preparing for your first FDA inspection and/or ISO audit generated a lot of interest, and a lot of follow-up questions from emerging…
MDR Transition and Technical Files: What You Need to Know
Recent changes to European regulations have sparked a lot of interest and intrigue, and even more questions. So, what specifically do medical device companies need to…
Rook QS Webinar: First FDA Software Updates in 16 Years
On Monday, November 22nd, Rook’s Kyle Rose and Andrew Wu, two of the industry’s foremost experts on quality and regulatory strategy in the software space, presented…
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…