Industry Perspectives - Design & Development
The Intersection Of ISO 13485 And ISO 14971 Under The Proposed FDA QMSR
The FDA's proposed update to the Quality System Regulation that was originally released in 1996 references ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes, which is in its third edition. Let's take a closer look.
The Role Of Failure Mode In ISO 14971:2019’s Hazard-Based Approach
In the context of ISO 14971:2019 and risk management for medical devices, manufacturers and designers are often confused about the implementation of hazard analyses and FMEAs, especially since this standard takes a hazard-based approach. In this article, Jayet Moon demystifies the topic.
Why Is Femtech Software Unreliable? + 3 Strategies For Improvement
Femtech (female health technology) has made significant progress toward bringing women’s health to the forefront of medical attention. However, a significant number of software-based femtech devices are not reviewed and regulated by the FDA and do not have to prove accuracy. What can we do as medtech developers to improve clinical relevance of these devices and software?
3 Key Benefits Of Deploying Edge AI At The Point Of Care
The point of care is shifting, taking place increasingly outside the hospital setting and moving into patients’ homes. However, cloud computing has some limitations. Edge inference is the practice of deploying machine learning models directly onto devices, allowing the data to be captured and processed at the point of care, rather than in the cloud.
Meeting & Exceeding User Needs For Wearable, Nearable Medical Devices
Big-picture messaging such as “improved outcomes” or “healthier life” are not enough to justify continued interaction with wearable and nearable medical devices or platforms. Instead, designers need to understand how they are asking users to engage and participate in the monitoring or treatment process and create useful, seamless interactions.
Increase In FDA Inspections + Whistleblower Complaints = Heightened Compliance Scrutiny
We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an uptick in whistleblower complaints. Why? And how can you navigate it? This article examines the issue.
The Road To ISO 13485 Certification: Tips For Effective Audits
Follow these best practices to prepare for and conduct an audit for your medical device quality management system compliance with regard to ISO 13485.
ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity & Supply Continuity
The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management, Q9(R1), was adopted on January 18. This article focuses on the guidance's new topics of subjectivity and the role of QRM in addressing product availability risks.
The FDA Regulatory Landscape For AI In Medical Devices
This article reviews the existing FDA programs impacting artificial intelligence (AI) / machine learning (ML) technologies in medtech, as well as the agency's priority list for releasing related guidances in 2023.
ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-based Decisions
The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.