Industry Perspectives - Design & Development

41. The Positive Impact Of The Voluntary U.S. Cyber Trust Mark On IoMT Devices 10/17/2023

    The recently proposed U.S. Cyber Trust Mark is a voluntary cybersecurity labeling program operated by the FCC. It will initially provide IoT manufacturers with a certification label that signifies their compliance with cybersecurity guidelines and best practices.

42. Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 1 10/6/2023

    All drug delivery manufacturing systems undergoing quality improvement projects involve teams to gather many inputs and then to analyze the data. This article, the first in a 3-part series, provides an overview and theoretical understanding of measurement system analysis using continuous gage repeatability and reproducibility (R&R) studies.

43. A Risk-Based Approach To Assess Particulate Generation For Cardiovascular Devices 10/3/2023

    The therapeutic and/or diagnostic uses of cardiovascular devices are broad, and the total length of time that a device remains within the cardiovascular system can range from minutes to the patient’s lifetime. This article examines risk evaluation of particulate matter generated by a device and introduced into the circulatory system.

44. Two Key Security Precautions To Protect Your Device — And Your Patients 9/25/2023

    A physically secure device doesn't ensure data security, just as shoring up data connectivity vulnerabilities doesn't preclude bad actors from physically damaging a device. But, a vulnerability assessment and penetration test can greatly improve your understanding of how safe a device is from a cybersecurity standpoint.

45. Risk Tool Selection With ICH Q9(R1) In Mind 9/19/2023

    This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like.

46. FDA's Grace Period For Medical Device Cybersecurity Is Over. Are You Ready? 9/18/2023

    The FDA had established a grace period for all medical device manufacturers to ensure that you are incorporating cybersecurity during the design and validation of cyber devices. The end date of the grace period, and the seminal date in medical device cybersecurity enforcement, is Oct. 1, 2023. Are you prepared?

47. 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.

48. 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.

49. 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.

50. 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.