Industry Perspectives - Design & Development

61. A Brief Guide To ISO 13485's Design Controls In Medical Device Development 9/15/2023

    Design controls play a crucial role in the medical device development process by providing a systematic approach to manage risks, design requirements, and verification and validation activities. Let's explore the key elements of ISO 13485 that will help you manage the process effectively.

62. The Critical Role Of Risk Mitigation & Vertical Integration In Successful Micro Molding 7/31/2023

    In this exclusive Q&A article, Alex Anderson, Sales Engineer at Accumold, systematically explores the crucial implications of vertical integration in micro molding projects.

63. Steps To Develop A Leak Test For Implantable Medical Devices 7/7/2023

    If you're developing an implantable medical device, you need to prove to regulators that it will function safely and effectively 10 years after implantation. However, there is no standard approach to follow, and before setting acceptance criteria, you'll need to find a way to test for leaks. Here is one effective method.

64. Combination Product QMS Requirements For The EU Market 6/30/2023

    Pharma companies are now building the capability to manufacture combination products in-house to increase flexibility and reduce dependency on third parties. This article shares key considerations for companies implementing a medical device QMS with regard to EU requirements.

65. An Agile Approach To Regulatory Information Management System Transformation 6/20/2023

    Life sciences industry regulators have become increasingly focused on data-driven processes as a means of managing marketing authorization submissions. But this requires that your regulatory information management system (RIMS) upgrades are in a state of continuous evolution and are approached holistically. 

66. Quality Engineers: Are You Making The Right Call? 6/1/2023

    As a quality engineer, a lot of us have had a project leader ask us to sign off on a project when the data has too many outliers. How do you navigate that situation?

67. The Intersection Of ISO 13485 And ISO 14971 Under The Proposed FDA QMSR 5/24/2023

    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.

68. The Role Of Failure Mode In ISO 14971:2019's Hazard-Based Approach 5/10/2023

    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.

69. Why Is Femtech Software Unreliable? + 3 Strategies For Improvement 5/4/2023

    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?

70. 3 Key Benefits Of Deploying Edge AI At The Point Of Care 4/28/2023

    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.