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Key Strategies for Successfully Executing the Design Transfer Process
Design Transfer is the critical process of moving a medical device from prototype or early development to full-scale production. It can be involved in scenarios such…
Essential Tips for Preparing for Your ISO 13485:2016 Stage 1 Audit
An ISO 13485:2016 audit is a comprehensive evaluation process conducted to verify that a medical device manufacturer’s quality management system (QMS) meets the requirements of the…
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…
Understanding the FDA’s Small Entity Compliance Guide for the LDT Final Rule
The U.S. Food and Drug Administration (FDA) recently introduced the Small Entity Compliance Guide (SECG) to accompany the Laboratory Developed Tests (LDT) Final Rule. This initiative…
What is A Pre-Submission (Pre-Sub)?
A Pre-Submission (Pre-Sub) is a type of Q-Submission used by medical device developers to seek feedback from the FDA on applications such as IDE, PMA, HDE,…
Keeping Up with the Machine: Predetermined Change Control Plans for Medical Devices
Machine learning (ML) revolutionizes the medical field by enabling faster disease detection, more accurate diagnoses, and personalized treatments. These advancements rely heavily on the vast amounts…
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,…
FDA Labeling Requirements for Point of Care vs. Home Use Devices
A critical decision in designing and developing a medical device is whether it will be used by trained professionals or the general population. This decision will…
Navigating the FDA’s Final Rule on Lab-Developed Tests – LDTs
On April 29th, 2024, the FDA introduced its much-anticipated Final Rule on Laboratory Developed Tests (LDTs), marking a significant milestone in regulating in vitro diagnostics. This…
Navigating Healthcare Cybersecurity: Section 524B of the FD&C Act
In our interconnected world, where medical devices are integral to patient care, cybersecurity stands as a paramount concern. The Food and Drug Administration (FDA), recognizing the…