Blog

Health Canada, the FDA, and the UK’s MHRA collaborated in 2021 to establish ten foundational principles aimed at promoting good machine learning practices (GMLP). These principles…
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…
Overview Artificial intelligence (AI) technologies have ushered in a new era in healthcare, fundamentally altering how medical decisions are made. These advancements extend across various domains…
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…
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…
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…
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…
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,…
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…
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,…