Author: Rita King

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Cybersecurity’s Impact on Health Systems

We are currently seeing significant technological advances in medical devices, hospital networks and patient care. As medical devices become increasingly interconnected via the Internet, hospital networks, other medical devices, and smartphones, there is an increased risk of exploitation of cybersecurity vulnerabilities, some of which could affect a device’s performance, functionality and safety to the patient....
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Human Factors Engineering

Human Factors Engineering for Medical Devices

In February 2016, the FDA released a guidance entitled, “Applying Human Factors and Usability Engineering to Medical Devices.” The intention of this document, in combination with IEC 62366-1:2015 Part 1: Application of usability engineering to medical devices, is to maximize the safety and effectiveness of devices for intended users, use and use environments. Its purpose...
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Transitioning to ISO13485:206

Transitioning to ISO 13485:2016

In the event that you have not heard, ISO 13485 has undergone a major revision. As a quick recap, ISO 13485:2003 was overhauled by the technical committees in order to align more closely with regulatory requirements. The new version introduces a risk-based approach. This doesn’t mean that the traditional process approach has gone away, it...
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The NEW ISO 13485:2016 – Procrastination Can Cost You

ISO 13485 is the international standard medical device companies follow to demonstrate their ability to consistently meet both customer and regulatory requirements with their devices and related services. Regulators worldwide, including the EU, Canada, Australia and Japan, have integrated ISO 13485 into their regulatory requirements. The standard is designed to be used by organizations throughout...
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Improving FDA Reviews of Combination Products

Just a few short weeks ago, Robert Califf, the US Food and Drug Administration (FDA) Commissioner nominee, endorsed an internal report that provided recommendations on how the FDA could improve reviews of combination products. Combination products include: Products comprised of two or more regulated components, such as drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically,...
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