Rook Quality Systems (RookQS), a leading provider of quality solutions, is proud to announce its strategic partnership with Trust Cybersecurity, a specialized cybersecurity testing service catering…
This post is part of a two-part series. You can read Part 1 here In the ever-evolving landscape of medical technology, the regulation of Laboratory Developed…
Why did the FDA release this document? The guidance document “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring” introduces a new policy…
What does the FDA consider to be a wearable medical device? The difference between the two classifications of wearable devices and general wellness devices can severely…
This post is part of a two-part series. You can read Part 2 here. Per the FDA commissioner, Dr. Robert M. Califf, and data from the…
![Steps the FDA Continues to Take to Strengthen the Premarket Notification [510(k)] Program](https://rookqs.com/wp-content/uploads/2023/10/9.23.23-Blog-Image-scaled.webp)
Last week, the U.S. Food and Drug Administration (FDA) released three new draft guidances to strengthen the 510(k) program and to advance the safety and effectiveness…
Receiving an audit notice from the FDA can be a daunting experience, but it also presents a great opportunity for your medical device company to demonstrate…
ISO 14971 and ISO 24971: Enhancing the Safety of Medical Devices through Effective Risk Management The development and manufacturing of medical devices are critical processes that…
Building trust with patients is one of the most important foundation blocks in the medical device industry. Developing patient trust is strictly driven by ensuring that…
Artificial intelligence (AI) is changing the world and the medical device realm, but in reality, it is a simple word: automation. In this blog post, we…