How Are You Managing Your Postmarket Cybersecurity Vulnerabilities For Medical Devices?

By Deb Bartel, 5th January 2017

At the end of 2016, the FDA published Guidance for Industry and FDA Staff, Postmarket Management of Cybersecurity in Medical Devices to inform industry of recommendations for managing postmarket cybersecurity vulnerabilities for marketed medical devices. This guidance emphasizes that manufacturers should monitor, identify and address cybersecurity vulnerabilities and exploits for their medical devices. What is in the FDA Guidance Document: This  … Read more

Is Your Medical Device Compliant With The Second Draft Of The WHO Global Model Regulatory Framework?

By Deb Bartel, 1st November 2016

In mid-2016, the World Health Organization (WHO) published the 2nd draft of Global Model Regulatory Framework for Medical Devices including IVDs. This document is intended to provide guidance to WHO Member States in developing and implementing regulatory controls relating to medical devices to ensure the quality and safety of medical devices. Since many modern medical devices contain software, developers of  … Read more

Are You Following the FDA Medical Device Cybersecurity Guidance?

By Deb Bartel, 18th February 2016

In January the FDA published draft cybersecurity recommendations for marketed medical devices to protect patient safety. What’s new in this draft FDA guidance document: Manufacturer’s Responsibilities This guidance emphasizes that medical device manufacturers should monitor, identify and address cybersecurity vulnerabilities.  This draft FDA document highlights that it is essential for device manufacturers to implement comprehensive cybersecurity risk management programs. These  … Read more

Are you ready for the FDA guidance on the design of Interoperable Medical Devices?

By Deb Bartel, 11th February 2016

If your electronic medical device exchanges data with other devices, you need to read the new draft guidance just published by the FDA.  This document contains recommendations intended to promote the safe and effective exchange of information between devices.  Make sure you and your team are aware of these best practices, so you can incorporate them into your medical device.  … Read more

What do you need to know about the new FDA guidance on Manufacturing Site Changes?

By Deb Bartel, 16th November 2015

Recently, the FDA drafted this guidance document to help the medical device industry make decisions around manufacturing site changes. This guidance is intended to help in managing the time frames for changes in manufacturing sites and the associate changes to processes, methods, procedures, qualifications and validations by helping industry predict when an FDA pre-approval inspection is likely to be required for  … Read more